Quarterly
Volume 11, Issue 1
January - March 2015
ISSN 2395 - 3624
President’s Message
Index
Contents
From the Editor’s Desk
•
Message from Editor
•
Executive Committee Members
•
Editorial Board
•
Our Deepest Condolences
Dear Readers,
The beginning of the New Year brought excellent news for
the AYUSH sector from Government by their announcing
& implementing “A Separate Department of AYUSH”
with no control by the Allopathic sector. We are also very
fortunate to have a dynamic, energetic and well wisher of
AYUSH system, Sh. Shripad Yesso Naik as Hon’ble State
Minister of Health & Family Welfare, AYUSH- Independent
Charge. AMAM also seeks to ensure that “AYUSH must
be under the control of AYUSH Experts only” and that a
Drug Controller & his team for the AYUSH sector should
be in the AYUSH Department only. Representation made
to Sh. Shripad Yesso Naik, Hon’ble State Minister of
Health & Family Welfare, AYUSH - Independent Charge is
reproduced for information to readers.
On behalf of AMAM, I extend my deepest condolences
to the Hamdard Privar on the sad demise of Janab Abdul
Mueed, the founder of Hamdard Dawakhana and President
of Hamdard National Foundation. Janab Abdul Mueed was
also the patron of AMAM. The demise of, Vaidya Shri
Chandrakant Prabhushankar Shukla “Charaka Vaidya”
is also mourned as a great loss not only to the Ayurveda
fraternity but the whole nation.
Wishing our readers happiness & prosperity in the year!!
Best wishes!!
President, Shri Devendver Triguna Ji
Updates
•
Centre Notifies Royalty Slabs for Biological
Resources
• Circular for participation in events from
Dept. of AYUSH
• AMAM Representation to Hon’ble State
Minister of Health & Family Welfare,
AYUSH
• CITES - An Introduction
Report
•
Conference on Mainstreaming AYUSH:
Cultural Heritage for Healing
Clinical Study
•
An Open, Prospective, Randomized,
Comparative Clinical Study on the
Safety & Efficacy of Dabur Shwasamrit
in the management of Chronic Bronchial
Asthma
Review Article
•
Concept of Shodhana, Bhavana,
Marana and Quality of Bhasmas
From the Editor’s desk
Dear Readers,
At the beginning, I congratulate Sh. Shripad Yesso Naik
for assuming the charge of Minister of Health & Family
Welfare, AYUSH- Independent Charge.
I extend my deepest condolences to the Hamdard Privar
on the sad demise of Janab Abdul Mueed, the founder
of Hamdard Dawakhana and the President of Hamdard
National Foundation. Janab Abdul Mueed was also one
of the patrons of AMAM. The demise of, Vaidya Shri
Chandrakant Prabhushankar Shukla “Charaka Vaidya”
is also mourned as a great loss not only to the Ayurveda
fraternity but to the whole nation.
In the first issue of the year, the section on updates
reproduces representations made by AMAM and various
notifications from Dept. of AYUSH. Glimpses of
conference - Mainstreaming AYUSH: Cultural Heritage
for Healing are also presented. For enhancement of
knowledge of our readers are presented an introduction
to CITES and an informative article on the Concept of
Shodhana, Bhavana, Marana and Quality of Bhasmas.
We wish to inform our readers that info Ayurveda has been
accorded ISSN Number (online) and the print version will
follow soon. We invite suggestions and feedback from our
readers, as also some articles they wish to contribute. We
also call for manufacturers of ASU Drugs and allied herbal
industry to join our association and make it stronger, as in
unity we stand and in unity we shall succeed.
Wishing our readers happiness & prosperity!!
Warm Regards,
Dr. J.L.N. Sastry
On Behalf of Editorial Board
A Publication of:
Association of Manufacturers of Ayurvedic Medicines
Reg. Office: 22, Sit-IV, Sahibabad, Ghaziabad-201010 (UP),
Tel: 01203378400, Fax: 0120 4552645
Correspondence Address: H-36, Connaught Place, New Delhi-110001,
Tel: 011-23350062, Fax: 011-23350063
Email: [email protected] website: www.amam-ayurveda.org
info Ayurveda, Volume 11, No.1 January - March 2015
Members of AMAM’S Executive Committee
Patron
Joint Secretaries
Sh. Ram Avtar Sharma
Shri Baidyanath Ayurved Bhawan Ltd.,
Dr. J.L.N. Sastry
Dabur India Limited
[email protected]
Sh. Abdul Mueed
Hamdard (WAKF) Laboratories
Sh. Pradip Burman
Dabur India Limited
Sh. Arun Chauhan
BACFO Pharmaceuticals (India) Ltd.
[email protected]
Dr. N. B. Brindavanam
Dabur India Limited
[email protected]
President
Vaidya Devender Triguna
Tel: 011-24354141
Vice President
Sh. Ajay Sharma
Shri Baidyanath Ayurved Bhawan Ltd.,
[email protected]
Sh. Asad Mueed
Hamdard (WAKF) Laboratories
[email protected]
Sh. Krishan Chutani
Dabur India Limited
[email protected]
Dr. Rangesh
The Himalaya Drug Co.
[email protected]
Hon. General Secretary
Sh. Pradeep Multani
Multani Pharmaceuticals Ltd.
[email protected]
Sh. M.J. Saxena
Sanat Laboratories Ltd.
[email protected]
Members
Dr. Anantha Narayana D B
Ph.D., Consultant
[email protected]
Sh. Amit Agarwal
Natural Remedies
[email protected]
Sh. Vijay Grover
Kamal Pharmacy, New Delhi
[email protected]
Treasurer
Sh. Tejinder Singh
Dabur India Limited
[email protected]
Editorial Board
Chief Editor:
Sh. Pradeep Multani, Honorary General Secretary AMAM
Chairman, Multani Pharmaceutical Limited
H-36 Connaught Place, New Delhi-110001
Editors:
Dr. J.L.N. Sastry, Joint Secretary, AMAM
Head- Healthcare Research
Dabur India Limited
Sh. Asad Mueed, Vice President, AMAM
Director, Hamdard (WAKF) Laboratories,
Sh. Ajay Sharma, Vice President, AMAM
President, Shri Baidyanath Ayurved Bhawan Ltd.
Dr. K. R. Kohli
Director of Ayurveda, Govt. of Maharashtra
Prof. (Dr.) S. Venkatraman
Former Director, C.L. Baid Metha College of Pharmacy, Chennai
Prof. (Dr.) K. Nisteshwar
Head - Department of Dravyaguna
Gujarat Ayurveda University, Jamnagar
Disclaimer: Articles in the newsletter are written by independent individuals
and News Clips of Upcoming Events, Govt. Notifications, Schemes have been
taken from different sources. Their opinion does not necessarily reflect those
of InfoAyurveda. They are put here for interest and reference only. None of
the contributors, sponsors, administrators, or anyone else connected with Info
Ayurveda in any way whatsoever shall be responsible for the appearance of
any inaccurate information or for your use of the information contained in
the newsletter.
2
Deepest Condolences
Janab Abdul Mueed
With profound grief we inform the passing away of ‘Janab Abdul Mueed’, the eldest son of the Founder
of Hamdard Dawakhana, Hamdard Hakeem Abdul Hameed on the 19th of March, 2015.
A Condolence meeting was held on 21st March 2015, on Saturday, 21st of March 2015 Qura’an
Khwani at Rabia Masjid, Jamia Hamdard Campus, Hamdard Nagar, New Delhi for eesal-e-sawab of
the departed soul.
Janab Abdul Mueed was the President, Hamdard National Foundation. He was also one of the Partons
of AMAM.
On behalf of our President, Vaidya Devendra Triguna; Executive Committee & all our members, we
offer our condolences to the Hamdard Parivar & our Vice-President, Shri Asad Mueed.
Honourable Vaidya Shri Chandrakant Prabhushanakar Shukla
Charaka Vaidya
Honourable Vaidya Shri CP Shukla, former Dean of the Institute of Post Graduate Training and Research
in Ayurveda, Gujarat Ayurveda University, Jamnagar, left for heavenly abode on 23rd March 2015.
Vaidya CP Shukla Ji was popularly known as ‘Charaka Vaidya’ for his profound knowledge of
Ayurveda treatise, the Charaka Samhita, and his expertise in putting it to practice. Though past 80,
he worked as an Ayurveda physician, but supplemented standard Ayurvedic practice with modern
tools and methods of investigation. This legend helped many patients live a normal life.. A quote from
Charaka Samhita depicts the entire world as a teacher, suggesting Vaidyas should study other systems
of medical knowledge in addition to Ayurveda has practiced this vision himself for over five decades.
His presence will always be missed by the Ayurveda fraternity.
info Ayurveda, Volume 11, No.1 January - March 2015
3
MAINSTREAMING AYUSH: CULTURAL
The Health Committee of PHD Chamber of Commerce
and Industry organized a conference cum Exhibition on
Mainstreaming AYUSH; Cultural Heritage for Healing
on October 31, 2014 at 1000 Hrs at PHD House , New
Delhi. The objective of the Conference was to sensitize
all the stakeholders regarding the significance and
benefits of AYUSH. The Hon’ble Minister of State (IC),
Ministry of AYUSH, Government of India, Shri Shripad
Yesso Naik was the Chief Guest on the occasion.
Inaugurating a Conference on “Mainstreaming AYUSH:
Cultural Heritage for Healing” under aegis of PHD
Chamber of Commerce and Industry here today, the
Minister informed that the government has approved
a independent drug controller for AYUSH that will be
separated from the drug controller of modern medicine.
Shri Naik also disclosed that Ministry of AYUSH has
asked the Finance Ministry to hike the budgetary
allocation for propagation and promotion of AYUSH
to an extent of Rs.2,700 crore for fiscal 2015-16 from
present level of Rs.400 crores, its Minister of State (I/C)
Mr. Shripad Yesso Naik informed. “The drug controller
for AYUSH would be provided with sufficient teeth to
regulate the AYUSH as per new policy prescription,
info Ayurveda, Volume 11, No.1 January - March 2015
who would also be provided with a mandate to issue
the certificate of pharmaceutical products (COPP)
for exports of AYUSH products”, said the minister
pointing out that manufacturers of AYUSH would not
be required to run from pillar to post to obtain it from
the current arrangements.
“Recruitment rules are being finalized for the new
drug controller and cabinet note being finalized for
new regulations of AYUSH products under the new
AYUSH health policy which would be unveiled very
shortly”, Mr. Naik said.
The Hon’ble Minister indicated that budgetary
allocations for AYUSH until now were meager at
about Rs. 400 Crores for fiscal 2014-15 which need
to be multiplied in view of the emerging importance
of evolving AYUSH systems and it has already been
proposed to the finance ministry to take it to the level
of Rs.2, 700 Crores for the next fiscal, beginning April
2015.
The fresh standards are also being worked out to ensure
that quality AYUSH products are made as per new
policy prescription so that such products are well tested
for their authenticity, credibility and quality.
4
HERITAGE FOR HEALING- A REPORT
In his welcome remarks, Senior Vice President PHD
Chamber Mr. Mahesh Gupta urged the government
to enhance the yearly allocation for AYUSH to an
extent of 20% of the total health budget allocations
so that money generated is utilized for the expansion,
diversification and broad basing AYUSH.
Mr. Pradeep Multani, Chairman, AYUSH Committee,
PHD Chamber in his theme address discussed several
issues faced by the Industry including Issues related
to COPP – Certificate of Pharmaceutical Products,
Skill Development and Training for AYUSH Students,
increase in AYUSH budgets, request for a system
where export of AYUSH raw materials in not hindered
by Forest Department officials of various States,
Financial Support for establishment & Upgrade Drug
Testing Laboratories. Subsidized Testing fees for micro
and small AYUSH Industry members to name a few.
During his theme address, he focused on the small scale
producers and manufacturers of AYUSH products.
The highlight of the conference was the release
of knowledge paper on Mainstreaming AYUSH:
Cultural Heritage for Healing prepared by TMRC
and PHD Chamber by the Hon’ble Minister and other
dignitaries
info Ayurveda, Volume 11, No.1 January - March 2015
Among those who spoke on the occasion were Joint
Secretary Ministry of AYUSH Mr. A K Ganeriwala and
President, AMAM & All India Ayurvedic Congress
Vaidya Devender Triguna.
The inaugural session was followed by the technical
session on Regulatory issues with respect to proposed
bill on AYUSH Drugs Bill & Implication with
ABS Guidelines for AYUSH industry. The session
was chaired by Dr. Dinesh Katoch, Joint Adviser,
Ministry of AYUSH, Government of India. Dr. J.L.N.
Sastry, Head Healthcare Research, Dabur Research
& Development Centre, Dr. N.B. Brindavanam, Bioresource Development Group, Dabur Research &
Development Centre, Dr. Vijendra Prakash, In charge,
Regulatory Affairs, Himalaya Drug Company and
Dr. Sanjeev K Chaudhary, Managing Director, SRL
Limited participated in the session. Dr Sastry in his
presentation discussed the proposed amendments
in Drugs & Cosmetic Act. , Dr. N.B. Brindavanam
discussed the Dr. Chaudhary shared the statistics on
efficacy of ant-diabetic Ayurvedic formulations. The
Conference ended by vote of thanks proposed by Mr.
Saurabh Sanyal, Executive Director, PHD Chamber.
5
AMAM seeks to ensure that “AYUSH must be under the control of AYUSH Experts only” and that a Drug Controller &
his team for the AYUSH sector should be in the AYUSH Department only. Representation made to Sh. Shripad Yesso Naik,
Hon’ble State Minister of Health & Family Welfare, AYUSH - Independent Charge is reproduced for information to readers.
Sh. Shripad Yesso Naik
AYUSH - Independent Charge
Hon’ble State Minister of Health & FamilyWelfare
101, AYUSH Bhavan, ‘B’ Block
GPO Complex, INA. New Delhi- 110023
21st March 20 15
SUB. : SERIOUS THREAT TO A.S.U.INDUSTRY.
Dear Mr. Shripad Yesso Naikji,
Association of Manufacturers of Ayurvedic Medicines (A.M.A.M.) is the apex
body of Manufacturers of Ayurveda, Unani & Siddha products. We are actively
involved in promoting the ASU sector as a whole.
Hon’ble Sir, the NDA Government gave the AYUSH sector an excellent boost
by announcing & implementing “A Separate Department of AYUSH” with NO
control by the Allopathic Department.
Sir, we are also honoured & thankful to the NDA Government for giving us a
dynamic, energetic, outstanding & well-wisher of AYUSH System, YOU - Mr.
Shripad Yesso Naikji, as our Hon’ble State Minister of Health & Family Welfare,
AYUSH -Independent Charge, New Delhi.
However in a MAJOR setback, it is being proposed that the “AYUSH Drug
Control Department” should be under the ALLOPATHIC Department control with
AYURVEDA Inspectors reporting to DCGI officials i.e. Allopathic Department.
AMAM seeks your URGENT intervention to ensure that “AYUSH MUST BE
under the control of AYUSH Experts ONLY” & that a Drug Controller & his team
for the AYUSH sector should be in the AYUSH Department only.
We seek your intervention to kindly ensure the above.
On the auspicious occasion of NAVRATRAS & start of the INDIAN NEW YEAR,
we wish you & all members of the AYUSH family an excellent & wonderful year
ahead.
With kind regards,
Sincerely,
For A.M.A.M.
(Pradeep Multani)
Hony. General Secy.
info Ayurveda, Volume 11, No.1 January - March 2015
6
CITES - AN INTRODUCTION
Dr. Kamakshi [B.A.M.S. (D.U.), D.N.H.E.]
Dr. H.S. Tiwari [M.D. (G.Ay.U. Jamnagar), M.B.A.]
Multani Pharmaceuticals Ltd., New Delhi
CITES is one of the oldest conservation and sustainable
use agreement which is in Existence. CITES means
Convention on International Trade in Endangered
Species of Wild Fauna and Flora. It is a treaty to
protect the Endangered Plants and Animals.
Exploited and over used wild Fauna & Flora becomes
extinct. CITES is an infect measure to protect them.
CITES convention includes provision and rules for
trade.
Aim of the CITES is to ensure that International trade in
specimens of wild animals and plant does not threaten
the survival of the species in the wild and it accords
varying degrees of protection to more than 35000
species of animals and plants.
CITES works by subjecting International Trade in
specimens of selected species to certain controls. All
import, export, re-export and Introduction from the
sea of species covered by the convention has to be
authorised through a Licensing system.
Plant and Animals species have been listed under
different Appendices of CITES according to the threat
to them and the control required over their use. There
are three Appendices. The Appendices comes under
Article-II of Fundamental Principles of CITES.
In Appendix-I there are about 305 species which are
threatened with extinction are or may be affected by
trade. Trade for such species is illegal and if granted
then that could be some exceptional circumstances
provided with licensing.
This list includes the species that are the most
endangered among CITES listed animals and plants.
There is a threat to their extinction if not taken care of.
Their import is not for commercial use and legal.
Appendix-II includes nearly about 29592 species
that are threatened with Extinction and could become
info Ayurveda, Volume 11, No.1 January - March 2015
extinct if measures not taken at the appropriate time.
These species are not necessarily threatened at the
moment, but may become so unless trade is controlled.
It also include species which are similar to species
already listed in the Appendix. International trade in
specimen of Appendix-II species may be authorised by
the granting of an export permit or re-export Certificate.
No Import permit is necessary for these species under
CITES, although some parties do require import permit
as part of their stricter domestic measures. Permits
or certificate should only be granted if the relevant
authorities are satisfied that certain conditions are
met, above all that trade will not be detrimental to the
survival of the species in the wild.
Appendix-III includes near about 13 species that
are included at the request of a party that already
regulates trade in the species and that needs the
cooperation of other countries to prevent unsustainable
or legal explantation. The species are not necessarily
threatened extinction globally. Trade in these species
is only permitted with an appropriate export permit
and a certificate of origin from the State of the member
company who has listed the species.
The CITES Species
Roughly 5,600 species of animals and 30,000 species of
plants are protected by CITES against over-exploitation
through international TRADE. They are listed in the
three CITES Appendices. The species are grouped in
the Appendices according to how threatened they are
by international TRADE. They include some whole
groups, such as primates, cetaceans (whales, dolphins
and porpoises), sea turtles, parrots, corals, cacti and
orchids. However, in some cases only a subspecies or
geographically separate population of a species (for
example the population of just one country) is listed.
The table below shows the approximate numbers of
species that are included in the CITES Appendices as
7
of 2 October 2013*.
Appendix I
FAUNA
Mammals
Appendix II
Appendix III
Reptiles
Amphibians
Fish
Invertebrates
300 spp. (incl. 11 popns) + 23 sspp. 501 spp. (incl. 16 popns) + 7 45 spp. + 10 sspp.
(incl. 3 popns)
sspp. (incl. 2 popns)
154 spp. (incl. 2 popns) + 10 sspp.
1278 spp. (incl. 1 popn) + 3 25 spp.
sspp.
80 spp. (incl. 8 popns) + 5 sspp.
673 spp. (incl. 6 popns)
40 spp.
17 spp.
126 spp.
3 spp.
16 spp.
87 spp.
63 spp. + 5 sspp.
2162 spp. + 1 sspp.
22 spp. + 3 sspp.
FAUNA TOTAL
630 spp. + 43 sspp.
4827 spp. + 11 sspp.
135 spp. + 13 sspp.
FLORA
301 spp. + 4 sspp.
29592 spp. (incl. 162 popns)
GRAND TOTAL
931 spp. + 47 sspp.
34419 spp. + 11 sspp.
12 spp. (incl. 2 popns) + 1
var.
147 spp. + 13 sspp. + 1 var.
Birds
(Cited at CITES.ORG) (updated on 2 October 2013)
CITES is an excellent step taken towards the conservation
of endangered species. But it is very unfortunate that the
number of species which are in Appendix-I is more than
Appendix-III. Infact it should be reverse then only we
can say that the rules are properly followed.
However it is important to note that species included in
one of the Appendix, all parts & derivatives on of the
species are also included in the same Appendix. Unless
the species is annotated to indicate that only specific
parts and derivatives are included.
Separate populations of a species may have different
conservation needs and be included in different
Appendices.
Traditional Medicine Practitioners uses a wide range
of natural products ranging from Plants, Animals to sea
products. It is a great threat to the Traditional Practitioners
if valuable important products get extinct. There is a
great demand of Ayurvedic Medicines worldwide and it
is increasing day by day. Due to this increased global
demand the pressure has increased over the Medicinally
important plants, animals & sea products like Picrorhiza
kurroa, Coral etc.
Efforts in finding solution should be made as if once the
plant, animal or sea products become extinct. It can’t be
info Ayurveda, Volume 11, No.1 January - March 2015
bring back.
CITES sets certain controls on species in trade to protect
them from Extinction. All Import, export, reimport etc.
is done only when the licensing authority has authorised
it. In accordance with Article-IX of the Convention,
Management, Scientific Authorities each parts to the
convention must designate one or more management
authorities competent to grant permits or certificates on
behalf of that party and one or more scientific authorities
to provide advice that International trade in any CITES
– listed species will not be detrimental to the survival of
that species. CITES Meeting held on 3rd March, 1973
at Washington DC signed several Articles which were
amended at Bonn on 22nd June, 1979 are as follows –
Article I – It includes the definitions which serves the
purpose of the convention. It defines species, specimen,
trade, re-export introduction from the sea, Scientific
Authority, Management Authority and Party.
Article II – It includes the Fundamental Principles
regarding Appendix-I, II & III that, what is to be included
under Appendix-I, II & III, How and when the Trade is
regulated.
Article III is on Regulation of Trade in specimen of
species included in Appendix-I. Trade, Export, Import,
8
Re-export, Introduction from the sea of any specimen of
a species included in Appendix-I shall be in accordance
with the provision of this Article.
Article IV is Regulation of Trade in specimens of
species included in Appendix-II. Trade in specimens of
species included in Appendix-II shall be in accordance
with the provisions of this Article.
Article V – Regulation of Trade in specimens of species
included in Appendix –III. Trade, Export, Import
and Re-export of specimens of species included in
Appendix-III shall be in accordance with the provisions
of this Article.
Appendix-I, II or III.
Article XV – It is regarding the Amendment to
Appendices I & II like what all provisions shall apply
in relation to Amendment to Appendix I & II at or
between meetings of the conference of the parties.
Article XVI – It is about Appendix-III and Amendment
there to.
Article XVII – If the Present convention needs any
Amendment than this Article deals with that.
Article XVIII – Resolution of disputes arisen between
two or more parties.
Article VI – Permits & Certificates granted under the
provisions of Articles-III, IV & V shall be in accordance
with the provision of this Article.
Article XIX – The present conventions shall be open
for signature at Washington until 30th April, 1973 and
thereafter at Barne until 31st December, 1974.
Article VII – This article includes Exemptions and
other special provisions relating to trade.
Article XX – The present Convention shall be subject
to ratification, acceptance or approval. Instruments of
ratification, acceptance or approval shall be deposited
with the government of the Swiss Confederation which
shall be the Depositary Government.
Article VIII – It includes the measures to be taken by
the parties.
Article IX – It includes the management and Scientific
Authorities.
Article X – It deals with the trade with states not party
to the convention.
Article XI – It states that secretariat shall call meetings
at least once every two years and parties shall review
the Implementation of the convention.
Article XII – It is about the secretariat and its
functions.
Article XIII – It deals with the International measures.
If the secretariat receives information about species
mentioned in Appendix-I or II is being affected
adversely by Trade. It shall communicate with parties
or Authorities concerned.
Article XIV – This article is an effect on domestic
legislation and International conventions that the
provisions of the present convention shall in no way
affect the provisions of parties to adopt strict domestic
measures restrictions or prohibiting trade, taking,
possession or transport of species not included in
info Ayurveda, Volume 11, No.1 January - March 2015
Article XXI - The present convention shall be open
indefinitely for accession. Instruments of accession
shall be deposited with the Depositary Government.
Article XXII – It is regarding the entry of the
convention into force.
Article XXIII – It is regarding the specific
reservation.
Article XXIV – It is about Denunciation that any
party may denounce the present Convention by written
notification to the Depositary Government at any time.
The denunciation shall take effect twelve months
after the Depositary Government has received the
Notification.
Article XXV – It is regarding the Depositary of the
present.
Refrences:
1.
www.cites.org
2.
www.cites.org/eng/disc/species.ph
9
Concept on Shodhana, Bhavana, Marana and Quality of Bhasma
Dr. J. P. Singh
Shree Dhanwantri Herbals
Amritsar
INTRODUCTION
The word ‘concept’ literally means the faculty of forming
an idea, and the faculty get rich by the knowledge
of past and present. In this phase of study a critical
review of Ayurvedic and modern literature regarding
Lauha, Mandura, their Bhasmas and Panduroga (iron
deficiency anaemia) has been carried out, which cover
all related information from ancient-most classics to
latest researches and trends regarding Lauha, Mandura
and Pandu roga i.e. iron deficiency anaemia.
To correctly appreciate the scientific nature of
Rasashastra, it is necessary to be acquainted with its
fundamentals specially with reference to physical
and chemical concepts. Rasashastra is the science
of pharmaceutics in Ayurveda. It is a treasury of
pharmaceutical processing’s of Shodhana, Marana,
Jarana, Murchhana etc. So this phase of study has been
started with the ideology regarding the fundamentals of
Rasashastra like concept of Shodhana, Bhavana and
Marana with ancient analytical parameters.
CONCEPT OF SHODHANA
Classical definition
Shodhana is a process of separation by which physical
and chemical impurities get separated from the
substances by treatment with various drugs.
It is a process by which blemishes are separated from
the substance by various processing like grinding, etc.
with specific drugs.
Shodhana is a process of removal of impurities from
substances by means of pharmaceutical processing of
Svedana, Mardana and Nirvapa etc. with particular
drugs. (RT 2/52)
Modified definition
Shodhana is a process of purification and detoxification
by which physical and chemical blemishes and toxic
info Ayurveda, Volume 11, No.1 January - March 2015
materials are eliminated and substances are subjected
for further processing. Some changes also taking
place apart from these, which may be beneficial for
therapeutic purposes.
Objectives
1. Elimination of physical and chemical impurities,
which are not desired.
2. Eradication or minimization of toxicity of the material.
3. Transformation of the hard and non-homogeneous
material to soft, brittle, ductile and homogeneous
material.
4. Induction of wanted qualities.
5. Potentiation of therapeutic efficacy of the drug
material.
6. Conversion of the material in suitable form for further processing.
7. Leads to unique and suitable physico-chemical
changes.
8. For direct therapeutic uses in some cases.
PROCEDURES
9. Abhisheka (sprinkling): The material is heated
strongly and the liquid media is sprinkled on it.
E.g. Mandura Shodhana.
10. Achushana (absorption): Oily content of certain
toxic materials is minimized through different absorption means, e.g. Bhallataka Shodhana.
11. Atapa / Agni Shoshana (drying): The material is
kept on fire or exposed to sun rays till its dryness
e.g. Shilajatu Shodhana.
12. Bharjana (frying or roasting): The material is fried
with specific liquid media on Mandagni (mild
heat), e.g. Gairika Shodhana.
1. Bhavana (levigation): The material is triturated
with prescribed liquid media for specific time pe10
riod. e.g. Hingula Shodhana .
2. Dhalana (melting and quenching): At first the
material is melted by intense heat and then poured
into a liquid media. E.g. Naga Shodhana.
3. Galana (melting and straining): The solid material is melted first by heating and then filtered
through a cloth e.g. Gandhaka Shodhana.
4. Mardana (trituration): The material is ground
properly with prescribed drug for specific period.
e.g. Parada Shodhana .
5. Nimajjana (dipping): The material is kept immersed in the prescribed liquid for specific period.
E.g. Vatsanabha Shodhana.
6. Nirjalikarana (evoparation of water): Whole
water content of the material is evaporated by
heating. e.g. Sphatika Shodhana .
7. Nirvapa (heating and quenching): The red hot
material is dipped into the prescribed liquid. e.g.
Lauha Shodhana .
8. Parishravana (straining): The solid material is
dissolved in suitable liquid media and separated
from insoluble impurities through straining. e.g.
Navasadara Shodhana .
9. Patana (sublimation): Through Patana Yantra
the material is heated to convert into vapour, from
which the material is regained again by condensing. e.g. Parada Shodhana .
10. Prakshalana (washing): The material is washed
with prescribed liquid to remove its physical impurities. e.g. Godanti Shodhana .
11. Prithakikarana (separation): Physical impurities
are removed. e.g. Guggulu Shodhana.
12. Swedana (boiling under liquid bath): The material is boiled in prescribed liquid media through
Dola Yantra method. e.g. Sankha Shodhana .
13. Vilayana (elutriation): The material is firstly dissolved in prescribed liquid media and left as such
for some time. Then the upper part of the liquid
containing the soluble drug material is decanted
into another pot leaving behind the impurities in
the bottom of the first pot. e.g. Shilajatu Shodhana
14. Types
Shodhana process is grossly subdivided into two major
categories as follows:
1. Samanya Shodhana: It is used as general
procedure for Shodhana of all drugs of a particular
group, in other words these drugs should be
purified individually through the same Shodhana
procedure. e.g. Samanya Shodhana of Dhatu .
2. Vishesha Shodhana: It is used as specific
procedure for particular drug material individually
not for a group. It should be applied after Samanya
Shodhana. e.g. Vishesha Shodhana of Lauha in
Triphala Kwatha.
Role of Media
It is very interesting that specific media is used for
Shodhana of particular substance like Triphala Kwath
for Shodhana of Lauha , Gomutra for Shodhana of
Vatsanabha , etc. So should be inferred that media plays
an important role in Shodhana process. Sometimes
media acts like solvent, to dissolve the material for
easy separation from the insoluble impurities like
in Guggulu and Navasadara Shodhana. Some other
cases media acts to eradicate toxic chemical substance
from the drug. Native realgar (Manahshila) is always
found, mixed with As2O3, which is a highly toxic
substance. Churnodaka (lime water) is generally used
for Manahshila Shodhana .4 White arsenic (As2O3)
readily dissolves in solutions of alkalis but realgar
(As2S2) is insoluble in alkali/Solutions. So here,
Churnodaka acts to eradicate highly toxic As2O3
from Manahshila. Some materials are used directly in
therapeutics after Shodhana, there media may provide
some organic and inorganic principles, which have
important role in the body. Media helps in physical
transformation of some metals and minerals. In Nirvapa
process repeated heating and quenching in liquid media
causes brittleness, breaking and size reduction of the
metals and minerals.
Changes during Shodhana process
(1) Physical changes
(a) Elimination of physical impurities: Kampillaka
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11
is separated from brick powder. Guggulu is separated from physical mixture. Shilajatu is separated
from insoluble physical impurities.
(b) Reduction in hardness: By repeated heating and
quenching, hardness of the metals and minerals
become less.
(c) Increase brittleness: By repeated heating and
quenching in liquid media. Cracks are seen on the
surface of metals and minerals and these become
brittle.
(d) Reduction in particle size: During Nirvapa process cracks are seen on the surface of metals and
minerals, and these are broken into coarse powder.
In Bhavana process mass of the substance become
powder form.
(2) Chemical changes
(a) Elimination of chemical impurities: During
Shodhana of native Makshika (CuFeS2) impurities
like arsenic get eliminated by heating.
(b) Formation of chemical compounds : Lauha when
heated upto redhot, reacts with atmospheric oxygen to form ferroso-ferric oxide, which is favourable to the body. Makshika when fried, sulphur (S)
is eliminated and iron and copper part convert into
oxide form.
(c) Change into desired compound: During Shodhana of Tankana and Kankshi water portion is evaporated and desired chemical compound is formed.
(3) Biological changes:
The ultimate objective of these physico-chemical
changes of the material is to increase its biological
availability means to potentiate its biological efficacy.
Reduction in particle size helps in absorption,
smoothness leads to non-irritability, and all chemical
changes make the material body friendly like Shodhita
Vatsanabha (Aconitum ferox purified in cow s urine)
is converted into cardiac stimulant, where as crude
Vatsanabha is claimed to be cardiac depressant, seeds of
Kuchila (Strychnos nuxvomica) purified in cow s milk
show CNS depressant activity, pentabarbitonehypnosis
potentiation, inhibited morphine induced catalepsy.
Anjana purified in juice of Bhringaraja (Eclipta alba)
is proved non-toxic to eyes in experimental animals.
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CONCEPT OF BHAVANA
Classical definition
It is the process in which the material is completely
submerged in prescribed liquid and triturated till its
dryness. (RT 2/49)
Modified definition
Bhavana is a process of wet grinding in which
materials are ground with particular liquid media for a
specific period facilitates in easy absorption or further
processing.
Objectives
1. To bring minute particles of the material in contact
with the liquid media.
2. Impregnation of properties of the media to the material.
3. Transformation of the coarse powder to finer
state.
4. To facilitate the material for further processing.
5. Leads to unique and suitable physico-chemical
changes.
6. To potentiate the efficacy of the material.
Amount of liquid media
1. Gravimetrically equal to the amount of material to
be levigated.
2. Volumetrically so much, that the material can be
immersed completely.
3. Volumetrically so much, that the material can be
made into dough.
4. Amount of liquid media should be taken so much,
that it can make the material wet throughout the
specific period of grinding.
Procedures
1. In case where the media is taken as decoction
form, the amount of dry herb should be taken
equal to the amount of material; eight times water
should be added to it and should be reduced to one
eighth by boiling. Then the decoction is added to
the material, as much that the material remains wet
for whole day. This process is continued for seven
days.
2. The material is mixed with liquid material and
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ground till the whole material becomes like
dough.
3. The material is mixed with particular liquid media
and ground continuously for the specific period.
Chief desired characters
1. Desired shape can be given to the material after
levigation.
2. It will turn into flat shape, if pressed between finger
tips.
3. It will be soft in touch.
Role of media
Liquid media facilitates in easy and smooth grinding,
it eliminates the problem of dust. In this process during
grinding the minute particles of the material come in
contact to the liquid media. Pellets can be prepared
after proper levigation, so it helps in further processing.
Media impregnate its active principles to the material
and make the material organic. Liquid media acts as
a binding agent also. In case of Kharaliya Rasayana
liquid media helps in preparation of pills. Every liquid
media possesses some inorganic material. In Bhasma
preparation, these inorganic contents are transferred
to Bhasma and acts as trace elements, useful for our
body. Particular media is mentioned for levigation of
specific material indicates some basic relation between
the particular media and specific material.
act as trace elements.
(2) Chemical changes
(a) Chemical reaction: During levigation, minute
particles of the material come in contact with the
liquid media and during grinding heat are produced.
So there may be every possibility of occurence
of chemical reaction between the material and
media.
(b) Formation of desired compound: In Marana
process, metals and minerals are mixed with drug
for incineration and there after levigated by liquid
media. Liquid media during grinding may helps in
chemical reaction between two. During Bhavana,
silver (Ag) reacts with sulphur (S) to form Ag2S.
(3) Biological changes
Reduction in the particle size helps in absorption of
the materials and increase bioavailability. Induction of
trace elements helps in fulfilling the body requirement
of trace elements and also acts in many physiological
processes. Formation of desired compound during
Bhavana process increases the therapeutic efficacy of
the material. Organic components of the liquid media
are transferred to the material to make it organo-metallic
or organo-mineral compounds, which are favourable to
the body.
CONCEPT OF MARANA
Changes during Bhavana process
(1) Physical changes
(a) Reduction in hardness: By continuous grinding
the hard material become soft in consistency.
(b) Increase in weight: The organic and inorganic
contents of the media are impregnated in the
material causing gain in weight.
Classical definition
The process which converts the purified metals and
minerals into Bhasma after subjecting them to levigation
and incineration is called as Marana .10
Modified definition
(c) Particle size reduction: By continuous and
repeated rubbing action between two surfaces
helps in reduction in particle size.
Marana is a process of transformation by which
purified and detoxified materials are transformed into
absorbable, adaptable and assimilable form.
(d) Binding agent: In Kharaliya Rasayana during
Bhavana liquid media acts as a binding agent.
Objectives
(e) Trace elements supplement: Every liquid media
contains some inorganic substances. In Bhasma
preparation the organic components are burnt but
the inorganic contents transfer to the Bhasma and
(2) Elimination of certain unwanted elements.
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(1) Reduction in particle size.
(3) Transformation into suitable compound form.
(4) To make the material non-irritant to the G.I. tract.
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(5) To increase potency and quality of the material.
(6) Conversion into absorbable, adaptable and
assimilable form.
(7) To make the material suitable for therapeutic uses.
Procedures
(1) Putapaka method
Purified and detoxified material is mixed with drug for
incineration (Maraka Dravya) and is levigated with
particular liquid media for specific period. Pellets are
made from the doughy mass after Bhavana. And these
pellets are kept in one earthen saucer allowed to dryness
and covered by another earthen saucer and junction is
sealed by mud smeared cloth. This SaravaSamputa is
subjected to Puta for incineration. After self cooling the
pellets are collected and ground to powder form. This
process is repeated for specified times. e.g. - Lauha
Marana , Abhraka Marana , Sankha Marana
Mishrana → Bhavana → Chakrikakaran →
Samputikaran → Shushkana → Putapaka → Mardana
and Grahana.
(2) Kupipakva method
Purified and detoxified material is mixed with specified
substances and is levigated by particular liquid media
for certain period. It is allowed to complete dryness
and filled in a Kachkupi covered by seven layers of
mud smeared cloth. The bottle is then subjected to
Valukayantra for indirect and homogeneous heating for
a certain period. After self cooling the bottle is broken
and prepared drug is collected from neck or bottom
of the bottle and ground to powder form. e.g. Parada
Marana , Tamra Marana.
Mishrana (Kajjali preparation) → Bhavana →
Shushkana → Kupipurana → Kupipaka (in Valukayantra
) → Kupitadana → Grahana . Saravasamputa
(3) ‘Niragni’ method
Purified and detoxified material is mixed with specified
substances (mainly Kajjali) and is levigated by
particular liquid media for certain period. The round
masses (Golaka) are prepared and kept on a copper
saucer and are covered by some specific leaves. Then
the saucer is subjected to sunlight for complete dryness.
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Then the saucer is covered by another saucer and
junction is sealed by mud smeared cloth. The Samputa
is subjected in Dhanyarasi for a specific period. There
after the round masses are collected and ground to
powder form. e.g. - Lauha Marana.
Mishrana → Bhavana → Golokikarana → Shushkana
→ Samputikaran → Niragnipaka in Dhanyarashi →
Grahana and Mardana .
In Process Highlight
* Bhavana : Previously described.
* Chakrikakarana; It is a process in which small, round,
flat pellets are prepared from levigated doughy mass
of substances facilitates uniform and homogeneous
heating.
Objective
(1) To increase the surface area.
(2) To facilitate uniform and homogeneous heating.
(3) For easy collection of the material.
Procedure
Small amount of levigated doughy mass is taken in
palm; a round mass is prepared by using another palm.
Then a flat shape is given by pressing from side, top
and bottom.
Shape and size
The shape of a pellet should be flat (Chakrika) or round
(Golaka). Flat pellets are preferred due to its more
surface area and less thickness facilitating uniform and
homogeneous heating means, all the portion inner and
outer should be heated uniformly.
* Samputikarana:
In this process pellets are subjected in two earthen
saucers for uniform and homogeneous heating and for
providing a suitable atmosphere.
Objective
(1) To facilitate uniform and homogeneous heating.
(2) To provide a suitable atmosphere.
(3) For easy collection of pellet
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(4) To protect from any contamination.
Puta - the heating grade:
Procedure
There are several types of Putas, mentioned in our
classics like Gajaputa, Kapotaputa, etc. Specific
measurement and number of cow dung cakes
should be used are also mentioned like for Gajaputa
measurement should be Rajahasta (56 cm) is length,
breadth and depth, and 1000 cow drug cakes should be
used. For particular material, specified Puta is used like
for Lauha Marana, Gajaputa is used. Each Puta can
provide a specific temperature range, and it is different
in every puta, depends on its measurement and cow
dung cake used. Likewise each material has a specific
melting point and specific temperature for occurence
of desirable chemical reaction and it is manifested in
the final product, in its colour, taste and consistency.
So far the material having high melting point and hard
in consistency generally higher type of heating grade
is used like for Lauha and Tamra Marana , Gajaputa
is used and for the material having low melting point
and soft in consistency generally lower type of heating
grade is used like for Naga Marana , Varaha Puta is
preferred.
Pellets are kept in one earthen saucer and allowed for
complete dryness. Then it is covered by another earthen
saucer and junction is sealed by mud smeared cloth.
And again it is allowed to complete dryness.
Properties of saucer
(1) It must be inert (should not react with pellets).
(2) It should not be so thick or so thin.
(3) It must be heat-stable.
(4) It should not be a good conductor of heat (so that
during self cooling, after heating the atmosphere within
the Samputa is maintained). Earthen saucer has all the
qualities, so it is preferred for Samputikarana.
* Putapaka:
It is a process of heating in a specific heating grade
(Puta) in particular atmosphere for a specified period,
leading to proper incineration of the material.
Objectives
(1) To provide a particular temperature pattern (no less
or more heating).
(2) Reduction in particle size.
(3) To facilitate proper incineration.
(4) To provide a suitable atmosphere for desirable
chemical reaction.
(5) To make the material ductile, smooth and
homogeneous.
(6) To potentiate the material for therapeutic purposes.
(7) To make the material absorbable, adaptable and
assimilable form.
Procedure:
Specific Puta should be choosen for particular material
like for Lauha Marana, Gajaputa should be taken
as a heating grade. The Puta is filled 2/3rd by cow
dung cakes then Saravasampata is kept on it and the
remaining 1/3rd portion of the Puta is filled by cow
dung cakes. Then the cakes are ignited. After self
cooling Samputa is collected from Puta , it is opened
and pellets are collected and ground to powder.
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Changes during Marana process
(1) Physical Changes
(a) Anapsumajjata: After Marana the material attains
so much light and fine in character that they cannot
break the surface tension of stagnant water.
(b) Rekhapurnatva: The material after Marana
becomes so fine that it can fill the furrows of the finger
tips.
(c) Laghuta: After Marana the particles of the material
become so much light in character.
(d) Reduction in particle size: By repeated levigation
and prolonged heating, particles of the material become
too much fine.
(e) Conjugation of trace elements: During Bhavana
, the active principles of the liquid media impregnate
to the material and during Putapaka only the inorganic
part of the active principles remains in a very minute
amount.
Chemical Changes
(a) Apunarbhavata: After Marana the Mrita material
cannot regain its original metallic state.
15
(b) Elimination of unwanted elements: Where sulphur
(S) is used as a drug for incineration, there extra
sulphur is eliminated by forming SO2 (sulphur
dioxide), where Parada is used as Maraka Dravya
(drug for incineration), get lost after Marana by
vapourisation at high temperature.
(1) Physical parameters
(c) Formation of desirable compounds: During
Marana process, the material is converted into
suitable (for body) compound form. Where
Gandhak (sulphur) is used during Marana , there
sulphide of the concern material may be formed.
This test is applied to study the lightness and fineness
of Bhasma. Varitara is floating character of Bhasma on
stagnant water surface. Varitara test can be considered,
based on the law of surface tension. Here the particles
of Bhasma attain so much fine and light character that
they cannot break surface tension of stagnant water.
Biological changes
(a) Shighravyapti: After Marana, the Bhasma becomes
easily absorbable and assimilable in the body and
spreads quickly in the body.
(b) Agnideepana :The Bhasma attains Agni stimulation
property after Marana. The ultimate objective
of the physico-chemical changes is to increase
the bioavailability of the Bhasma. Reduction in
particle size helps in easy absorption. Formation
of desirable chemical compound helps to perform
specific therapeutic activity and the trace elements
fulfill the demands of trace element in the body.
CLASSICAL ANALYTICAL PARAMETERS OF
BHASMA
Ancient scholars of Rasashastra were so much wise
that they have mentioned the analytical parameters
for standard and quality production. They have also
mentioned the procedures to analyze these parameters.
All these parameters are dealt with different stand point
to test the perfectness of Bhasmas. Although most
of these tests are based on organoleptic methods of
examination, but some tests indicate specific chemical
assessment.
These parameters can be divided into two groups
(1) Physical parameters: Varitara, Unam test,
Rekhapurnata, Slakshnatvam, Susukshma, Anjana
Sannibha.
(2) Chemical parameters Varna, GataRasatva,
Nishchandratvam, Apunarbhavata, Niruttha.
info Ayurveda, Volume 11, No.1 January - March 2015
To assess the physical properties as lightness, fineness,
consistency etc. the below mentioned parameters are to
be considered as the physical tests.
(a) Varitara
Procedure
Take clear transparent water in a transparent glass.
Now take a little amount of Bhasma in between index
figure and thumb, sprinkle it slowly on stagnant water
surface from a short distance. The properly incinerated
Bhasma will float on the surface of water.
(b) ‘Unama’ test
It is further reassessment of Varitara test
Procedure
A grain of rice is to be kept carefully on the layer of
floated Bhasma. Observe whether the grain floats or
sinks. If the grain remains as it is on the layer, then
the Bhasma can be considered as excellent (properly
prepared).
(c) Rekhapurnata
This test is applied to study the micro fineness of
Bhasma. The Bhasma particles should be of minimum
size for the easy absorption and assimilation in the body.
The large particle may cause irritation to the mucous
membrane of gastrointestinal tract and cannot be
absorbed properly. The Bhasma should be so microfine
that it can fill the furrows of finger tips.
Procedure
A little amount of Bhasma is rubbed in between the
index finger and thumb. It is to be observed whether
the particles can fill the furrows of finger tips. If the
Bhasma attains the microfine character so as to fill the
furrows, it may be considered as genuine (properly
incinerated).
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(d) Slakshnatvam
It is the tactile sensation produced by Bhasma by simple
touch with finger tips. The properly incinerated Bhasma
attain this quality. Slakshna Bhasma can be absorbed
and assimilated in the body without producing any
irritation to the mucous membrane of gastrointestinal
tract.
(e) ‘Susukshma
It indicates microfineness of the Bhasma preparation.
This character of Bhasma can be perceived by Varitara
and Rekhapurnata tests. Properly prepared Bhasma
must be Sukshma, so that it can be absorbed in the body
easily.
(f) Anjana Sannibha
Anjana is smooth in character and it does not create
any irritation whenever applied. Properly incinerated
Bhasma should have the same characteristics like
Anjana. It must be smooth and should not create any
irritation to the mucous membrane of gastrointestinal
tract.
(2) Chemical parameters
To assess the chemical changes as compound
formation etc. the below mentioned parameters are to
be considered.
(a) Varna
It indicates the colour of the Bhasma. A specific colour
is mentioned for each Bhasma. And alteration in this
specific colour suggests that the Bhasma is not prepared
properly. Because a particular metallic compound is
formed during Bhasma preparation and every chemical
compound possesses specific colour.
(b) Gata Rasatvam
Every metal has its specific metallic taste. The properly
incinerated Bhasma of a metal should be tasteless on
taste perception. It indicates transformation of the
particular metallic taste to tasteless compounds by
unique pharmaceutical procedure.
(c) Nishchandratvam
The Bhasma must be Nischandra (lustreless) before
therapeutic application. Chandratva (lustre) is a
character of metal. After proper incineration the lustre
info Ayurveda, Volume 11, No.1 January - March 2015
of metal should not remain. So in Bhasma form,
metallic character of the metal should be changed.
This test indicates change of the specific metallic lustre
to lustreless compound after incineration. This test is
applicable to metallic and Abhraka Bhasmas.
Procedure
Observe the Bhasma preparation in bright sun light,
whether the lustre is present or not, if the lustre is still
present, it indicates the need of further incineration.
(d) Apunarbhavata
This test indicates the Bhasma s irreversible state of
becoming again the same metal or mineral. Apunarbhava
means incapability to regain the original metallic form.
This test is indicated for metallic Bhasmas. It reflects
the proper or improper incineration of Bhasma. The
properly incinerated Bhasma should not return to its
natural metallic form.
Procedure:
The Bhasma is mixed with equal quantity of Mitra
Panchaka (seeds of Abrus precatorius, honey, ghee,
borox and jaggery) and it is sealed in Sarava Samputa
(earthen pots), thereafter, the similar grade of heat used
for the preparation of the particular Bhasma is applied
and on self cooling product is observed. Lustred
particles in it shows presence of free metal which is
indicative of improper incineration.
(c) Niruttha
Niruttha test is to be considered as inability to regain
the metallic form as after proper incineration the
metal is transformed to its compounds. So it cannot
regain the original metallic form on the same grade of
temperature for incineration. This test is applicable to
metallic Bhasmas only.
Procedure
Bhasma is mixed with a fixed weight of silver leaf. It
is kept in a Sarava Samputa (earthen pots) and similar
grade of heat is applied as for preparation of Bhasma
and after self cooling, weight of silver is taken. Increase
in weight of silver leaf indicates improperly prepared
Bhasma.
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An Open, Prospective Clinical Study on the Safety & Efficacy of Dabur
Shwasamrit in the Management of Chronic Bronchial Asthma
Investigator - Dr. Laxman Prasad, Lecturer, Dept. of Kayachikitsa
Place of Study: Dhanwantry Ayurvedic Hospital, Chandigarh
Study Year: March 2005
INTRODUCTION
Bronchial asthma is a chronic inflammatory disorder
of the airway and common global distressing diseases
affecting 3-5% population with significant ethnic, socio economic and regional variations. Asthma causes
recurring periods of breathlessness, chest tightness,
wheezing and coughing that often occurs at night or
early in the morning making the condition worse.
The prevalence of asthma worldwide is around 200 million with a mortality of around 0.2 million per year and
an increasing morbidity and mortality, as well as health
care burden from asthma have been recognized lately.
The estimated burden of asthma in India is more than
15 million. A cross-sectional study conducted among
Indian children showed high prevalence of bronchial
asthma among the 12-13 years age group.
expectoration, giddiness and feeling of little comfort
in erect posture. Several modalities of treatment have
been described for Tamaka svasa in Ayurvedic texts.
Shwasamrit is a poly herbal Ayurvedic formulation
intended to provide relief from symptoms of chronic
bronchial asthma. It comprises herbs such Yastimadhu,
Kantakari and Shirish Chhaal which are reported to
possess individual therapeutic efficacy in management
of asthma. The present study investigated the efficacy
of Shwasamrit in symptomatic management of chronic
bronchial asthma. Results were evaluated on basis of
improvement in subjective, objective and safety parameters from baseline to the end of study period.
1. AIMS & OBJECTIVES
Although asthma cannot be cured but clinical episode
can be prevented and controlled by proper management.
1. To evaluate the efficacy of Shwasamrit in symptomatic
management of bronchial asthma
Bronchodilators, mast cell stabilizers, anti-allergics
and immunosuppressives are available modern treatments for asthma, but not without harmful effects to the
body. In spite of enormous advances asthma continues
to puzzle the physician from the point of view of treatment because the disease may result in the impairment
of respiratory function from milder degree of disabilities to life threatening asphyxiation.
2. MATERIAL AND METHOD
The review of the Ayurvedic literature reveals that a
similar condition Tamak svasa was known since ancient times and symptoms of asthma can be correlated with that of Tamak svasa, a condition arising due
to disturbances in equilibrium of the body’s humors
which induce the inflammation of airways, breathlessness, bronchospasm, wheezing sounds, difficulty in
info Ayurveda, Volume 11, No.1 January - March 2015
2.1 Study Design
The study was an open and prospective clinical study
2.2 Study Product
Composition: Shwasamrit is prepared from extract of
Glycyrrhiza glabra, Solanum xanthocarpum, Albizia
lebbeck, Adhatoda vasica, Clerodendrum serratum,
Tinospora cordifolia; powders of Terminalia belerica,
Curcuma longa, Aegle marmelos, Piper nigrum, Piper
longum, Cinnamomum zeylanicum, Cinnamomum
tamala and Eletaria cardamomum
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2.3 Subject Recruitment and Screening
Study subject were recruited after due consideration of
inclusion and exclusion criteria and obtaining a prior
written informed consent. Approval of Institutional
Ethics Committee (IEC) was obtained before study
initiation.
2.3.1 Inclusion criteria
Males & females in the age range of 18 to 60 years who
were suffering from mild to moderate Chronic Allergic
Bronchial Asthma (both atopic as well as non-atopic)
as per NAEPP 1997 revised guidelines, were medically
stable with normal LFT, RFT and Haemograms,
were not in acute attack of bronchial asthma and who
were capable of understanding and signing informed
consent
2.3.2 Exclusion criteria
Subjects suffering from severe or very chronic form
of asthma, those with concurrent pulmonary disease
(pulmonary hypertension, cystic fibrosis, sarcoidosis,
bronchiectasis, hypersensitivity pneumonitis, restrictive
lung disease etc.), or suffering from psychological
conditions, systemic and venereal diseases, HIV +
subjects, pregnancy/ lactation and females planning
to conceive in near future and subjects who were not
willing to sign informed consent or come for followup when required or participating in any other clinical
trials were excluded.
66 subjects were recruited in the study. At baseline,
detailed history and complete physical examination
were carried in all the patients for assessment of
symptoms like dyspnoea, tightness in the chest, ronchi
and they were advised treatment as given below.
2.4 Treatment Schedule
Recruited Subjects were advised Shwaasamrit at doses
of 6 g orally twice a day for 12 weeks.
Patients were advised to continue any allopathic
treatment they were already taking until advised
for a change. It was decided that any subject who
develops severe acute asthmatic episode amounting
to hospitalization would be withdrawn from the study.
info Ayurveda, Volume 11, No.1 January - March 2015
Any ADR were recorded in CRF’s.
2.5 Brief Visit Details
Evaluation of therapeutic response was carried out
over 5 follow up visits (Visit 1 to Visit 5) at 2,4,6,8
and 12 weeks from baseline and for further two weeks
after cessation of treatment. At every visit, a careful
observation about the decrease or withdrawal of
modern standard treatment was made.
2.6 Therapeutic or Clinical End Points Analyzed at
the Conclusion of Study
2.6.1 Therapeutic end point: 12 weeks of treatment
with study product with or without improvement in the
clinical condition of study subjects
2.6.2 Clinical end points Relief of symptoms of
bronchial asthma, decrease in the severity of attack,
Decrease in the background modern medicines like
bronchodilators/steroids
2.7 Parameters of Assessment:
Subjective Parameters
•
Improvement in Symptoms of Asthma viz.
dyspnoea, wheezing, cough
•
Global Patient Evaluation of Asthma Control on
VAS
Objective parameters
•
Pulmonary Function Test (PFT) using the Spirometer.
•
Clinical scoring for Asthma control on Visual Analogue Scale (VAS)
•
Changes in Serum IgE levels
•
Assessment of Quality of life in AsthmaticsAbsolute Eosinophil Count (AEC)
Safety parameters
•
Liver & Renal function Tests (LFT & RFT)
•
Haemogram (Hb, TLC, DLC), ESR,
19
2.8 Statistical Analysis:
Data was expressed as Mean ± SD & analyzed by using
Repeated Measures ANOVA Model and paired T-test
from baseline to the end of study at significance level
of 0.05 using Statistical Analysis System (SAS) version
9.1.3. The study adopted last observation carried
forward (LOCF) principle for missing data.
3. OBSERVATIONS & RESULTS
66 subjects were recruited in the study of which 51
subjects completed the study. 15 subjects dropped out
for reasons other than those related to study/ study
product.
3.1 Effect of Therapy on Symptoms of Bronchial
Asthma (VAS)
3.1.1 Dyspnoea
3.1.1.1 Presence of Dyspnoea: Dyspnoea was
present in 80.4% subjects at baseline. After
12 weeks of therapy, incidence of dyspnoea
reduced and was present only 35.3% subjects.
Relief from dyspnoea was observed in 45.1%
subjects.
3.1.1.2 Severity of Dyspnoea: The severity of
dyspnoea was scored over 10 points on VAS. Reduction
in baseline mean VAS score of dyspnoea was observed
visit 1 onwards and continued throughout the study
period. At the end of the study, significant (p<0.001)
reduction in dyspnoea was observed with 76.67%
improvement (Table 1).
3.1.2 Cough
Cough was present in 86.3% of subjects at the baseline.
Reduction in cough was observed visit 1 onwards and
continued throughout the study. At visit 5 cough was
present in 31.5% subjects only and relief from cough
was observed in 54.55% subjects (Table 1).
3.1.3 Wheezing
Wheezing was present in 74.51% subjects at the
baseline. Reduction in wheezing was observed visit 1
onwards and continued throughout the study. At visit
info Ayurveda, Volume 11, No.1 January - March 2015
5, wheezing was present in 33.4% subjects only, relief
from wheezing was observed in 41% subjects (Table
No. 1)
Table 1: Per cent Reduction in Incidence of
Symptoms of Bronchial Asthma
Symptom of Bronchial
Asthma
Dyspnoea
Cough
Wheezing
Baseline
12 weeks
80.4
35.3*
86.3
31.5
74.51
33.4
* Significant (p<0.001)
3.1.4 Severity of Asthmatic Attack
The intensity of asthmatic attacks graded as severe,
moderate and mild was found to be 13.7%, 25.5% and
60.8%, respectively at baseline which reduced to 0%,
3.9% and 82.4%, respectively at the end of study period.
11.8% subjects did not report any further incidence of
asthmatic attack till the end of study duration.
3.1.5 lgE Values
20 subjects had increased IgE levels at baseline which
decreased at the end of the study. This reduction was,
however, statistically not significant (Table 2).
3.1.6 Absolute Eosinophil Counts (AEC)
13 subject showed increased AEC at baseline which
reduced significantly (p<0.001) at the end of study
(Table 2).
Table 2: Effect on AEC and IgE Values
Symptom
Asthma
Dyspnoea
Cough
Wheezing
of
Bronchial Baseline
80.4
86.3
74.51
12 weeks
35.3*
31.5
33.4
* Significant (p<0.001)
3.1.7 Clinical Scoring for Asthma Control
Scores of Asthma Control on VAS showed significant
improvement from baseline at the end of the study
with 93.62±8.87 % control in clinical condition from
baseline (Table 3).
20
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