ISBN 978-93-5173-179-3 http://www.ayurlog.com ISSN 2320-7329 Vol. 3 Special issue*- 16th Feb. 2015 Ayurlog: National Journal of Research in Ayurved Science A Web based quarterly online published Open Access peer reviewed National E-journal of Ayurved “A prospective clinical study to evaluate the efficacy of pradarripu rasa in comparison with shalmali ghruta in the management of raktpradar.” 1. Nitika Sahebrao Badhiye, 2.Jayashree S. Deshmukh 1. Author.-P.G. Scholar,Department of PrasutiTantra&StreeRoga, CSMSS College of Ayurveda & Hospital, Aurangabad. 431001. 2.Guide : Head of Department, Department of PrasutiTantra&StreeRoga, CSMSS College of Ayurveda & Hospital, Aurangabad. 431001 ABSTRACT: Raktapradar is one of the main gynecological disorders. A condition associated with severe bleeding may be accompanied with menstruation or may not be. Ayurvedic texts have described a variety of treatment options in the management of “Raktapradar”. Despite of wide treatment options for its management which have multiplied over the recent years, yet considering the factors such as age, parity & wishes of the patient with regard to contraception, future pregnancy etc, which is non-hormonal, non surgical, effective & without any adverse effects is the needed. Pradarripu Rasa and ShalmaliGhrutaare mentioned in Yogratnakar in the management of Raktapradar. Both drugs are easily available, easy to consume and it is cost effective also.Therefore the present study INTRODUCTION Raktapradar1 is one of the main gynecological disorders. A condition was carried out for comparing clinical evaluation of the efficacy of both drugs. Total 60 patients were selectedby using purposive sampling method which was divided in 2 groups.The treatmentconducted for duration of 3 menstrual cycles.The responses to the treatment were recorded by parametersand therapeutic effects were evaluated by symptomatic relief. In the present study, according collected data, it is observed that both the drugs i.e. Pradarripu Rasa and Shalmalighrutahas provided significant relief in all the symptoms of Raktapradar.As total comparison of both Group drugs mentioned that Group A drug (Pradarripu Rasa) is quite effective than Group B drug ( ShalmaliGhruta). Key words – Raktapradar, Pradarripu Rasa, ShalmaliGhruta, associated with severe bleeding may be accompanied with menstruation or may not be.Raktapradar is a debilitating disorder; the woman requires rapid, safe and effective treatment.In the female the reproductive system has a great importance and any disease in this system 1 *Special Issue for “National Seminar- Practical approach in Prasutitantra And Streerog 2015” ISBN 978-93-5173-179-3 http://www.ayurlog.com ISSN 2320-7329 Special issue*- 16th Feb. 2015 Vol. 3 Ayurlog: National Journal of Research in Ayurved Science A Web based quarterly online published Open Access peer reviewed National E-journal of Ayurved will seriously affect her health and happiness and also it proves to be a great discomfort. Raktapradar is one among extensive range of occurrence. Ayurvedic texts2 have described a variety of treatment options in the management of “Raktapradar”.This is seen in 15% of all patients attending the Strirog&Prasutitantra O.P.D. from puberty to menopause. In the absence of any organic pathology, medical therapy3 is the first choice of treatment for controllingRaktapradar. However the conventional treatment with hormones has its limitations. It is associated with their side effects and is contraindicated in women with diabetes, hypertension and cardiac diseases often occurring around premenopausal age. Hence there is a need for a herbal drug that can be used for all patients to tide over this temporary phenomenon. Good numbers of researches have brought few recipes sufficiently efficacious; however the attempt to find new recipes or remedies never 4 ends.Pradarripu Rasa andShalmali 5 Ghruta are mentioned in Yogratnakar in the management of Raktapradar. Both drugs are easily available, easy to consume and it is cost effective also. So this study has been selected. AIM & OBJECTIVES Aim- To study the efficacy of Pradarripu Rasa in comparison with ShalmaliGhruta in Raktapradar. Objectives1. To compare the symptomatic relief by them on Raktapradar. 2. To carry out a comprehensive literary study of Raktapradar. MATERIALS AND METHODS Randomly selected 60 patients of Raktapradar attending OPD and IPD department ofstreeroga&prasutitantrawere included in study and divided into 2 groups. Group A and Group B All the patients fulfilling inclusion and exclusion criteria were selected for the study with fully informed consent. Methodology Group A Group B No of Patients 30 30 Drug Pradarripu rasa ShalmaliGhrita 1000 mg Matra(per ( 500 mg day) BD) 20 ml (10 ml BD) Anupan KoshnaJala Godugdha Duration 15 days 15 days Sevankal Twice a day Twice a day 2 *Special Issue for “National Seminar- Practical approach in Prasutitantra And Streerog 2015” ISBN 978-93-5173-179-3 http://www.ayurlog.com ISSN 2320-7329 Special issue*- 16th Feb. 2015 Vol. 3 Ayurlog: National Journal of Research in Ayurved Science A Web based quarterly online published Open Access peer reviewed National E-journal of Ayurved Followup After next menstrual cycle. After next menstrual cycle. No of follow ups 2 2 SELECTION CRITERIA Inclusion Criteria Patients willingly participated in the trial and given consent form. Patients having textual symptoms of Raktapradar were taken as subjects for study. Age group of patients between 18 to 50 years. Patients having symptoms of Raktapradar that is excessive & irregular PV bleeding. Hb % above 7 gm% Exclusion Criteria Patients unwillingly participated & associated with other complications such as Malignancy fibroids Associated with IUCD Systemic disorders Infections like Chlamydia and tubercular cervicitis etc Threatened or spontaneous or incomplete abortion Clinical Study A single blind randomize clinical trial was carried out. Selected patients were randomly divided into two groups. o Group A & Group B A special case paper was prepared to note the history & clinical findings of the patients before during & after the treatment. The treatment started on day of counseling, for 15 days and 2 such menstrual cycles were monitored for observations which were noted in the tabular form. During the course of treatment both groups were advised similar dietary & behavioral instructions. ASSESSMENT CRITERIA OF THE WORK -Gradation of symptoms Sr . n o. Sign & symptoms score 1 score 2 score 3 1 Duration of flow ( Raja pravrutti Kala) 5 days 7 + days+ 9 days + 2 Amount of blood loss (No of pads/ day) (Raja Pramana) 3-4 4-5 5+ 3 colour(Raja Varna) Bright red Brisk red Dark red 3 *Special Issue for “National Seminar- Practical approach in Prasutitantra And Streerog 2015” ISBN 978-93-5173-179-3 ISSN 2320-7329 http://www.ayurlog.com Vol. 3 Special issue*- 16th Feb. 2015 Ayurlog: National Journal of Research in Ayurved Science A Web based quarterly online published Open Access peer reviewed National E-journal of Ayurved 4 Clots in bleeding (Raja Swaroop) + ++ +++ 5 .HB % (Pandutva) Hb> 10 Hb> 8 Hb> 7 6 Weakness ( Daurbalya) + ++ +++ 7. Lower abdomen pain ( Adhodarsho ol) + ++ +++ Investigations • BT • CT • HB% • USG (Pelvis) Investigations done as needed. Follow up Patients follow up for 2 consecutive menstrual cycles. OBSERVATION AND RESULTS Total 42 patients were taken in group A and 36 patients were taken in group B.Out of which 30 patientsfor each group were selected randomly for the project work. All the selected patients were thoroughly examined and diagnosed and selected, based on exclusive and inclusive criteria. The assignment revealed the following statistics. Discussion on Observations– Age: In the present study, maximum no. of patients i.e. 33% were from the age group of 21-25 years. Education: In the present study the maximum 90 % patients could literate. Occupation: In the present study maximum 46.67 % patients were Housewives. Economical Status: Majority of the patients i.e. 43.33 % belonged to middle class. Religion: In the present Study Hindus were 60 %. Marital Status The present study shows that 73.67 % patients were married. Diet Pattern: Maximum numbers of patients i.e. 56.67% of this series were mixed vegetarian. Addiction: The present study revealed that majority of the patients i.e. 51.67 % were not having any type of addiction. Prakruti: Maximum no. of patients i.e. 46.67 % were having pittavataprakriti Locality: In the present study, 61.67% were urban inhabitants, while 38.33 % were rural in habitants. Aakruti: In the present study, 43.33 % patients were having madhyamaaakruti. 4 *Special Issue for “National Seminar- Practical approach in Prasutitantra And Streerog 2015” ISBN 978-93-5173-179-3 ISSN 2320-7329 http://www.ayurlog.com Special issue*- 16th Feb. 2015 Vol. 3 Ayurlog: National Journal of Research in Ayurved Science A Web based quarterly online published Open Access peer reviewed National E-journal of Ayurved Nidra: The present study showed that majority i.e. 48.67 % patients were having Prakrutnidra. Agni:The present study showed that majority i.e. 65 % of the patients were having Mandagni. Koshtha: The present study showed that maximum i.e. 45% patients were having mruduKoshtha. COMPARATIVE ANALYSIS: Statistical Analysis6:The null hypothesis, H0: The effect of treatment on all symptoms in Pradarripu Rasa (Group A) is not significant than in ShalmaliGhruta(Group B). The alternative hypothesis Ha: The effect of treatment on all symptoms in Pradarripu Rasa (Group A) is significant than in ShalmaliGhruta(Group B). All the values in following tables are calculated by using Mann – Whiteny test for subjective criteria and Unpaired t test for the objective criteria. Symptoms N Raja pravrutikala 55 Mean of Group A 1.75 Mean of Group B 1.407 S.D(+) of Group A 0.7 S.D(+) of Group B 0.636 S.E.(+) of Group A 0.132 S.E.(+) of Group B 0.122 U 273.5 U„ 482.5 P <0.05 As the p value is less than the significance level alpha = 0.05, we should reject the null hypothesis H0 and accept the alternative hypothesis Ha, i.e. Pradarripu Rasa (Group A) is significant than in ShalmaliGhruta(Group B) for Rajapravrutikala. Symptoms N Raja pramana 59 Mean of Group A 1.414 Mean of Group B 1.267 S.D(+), of Group A 0.627 S.D(+), of Group B 0.583 S.E.(+), of Group A 0.116 S.E.(+), of Group B 0.106 U 376 U„ 494 P <0.05 As the p value is lower than the significance level alpha = 0.05, we should reject the null hypothesis H0 and accept the alternative hypothesis Ha, i.e. Pradarripu Rasa (Group A) is significant than in ShalmaliGhruta(Group B) for Raja pramana 5 *Special Issue for “National Seminar- Practical approach in Prasutitantra And Streerog 2015” ISBN 978-93-5173-179-3 ISSN 2320-7329 http://www.ayurlog.com Special issue*- 16th Feb. 2015 Vol. 3 Ayurlog: National Journal of Research in Ayurved Science A Web based quarterly online published Open Access peer reviewed National E-journal of Ayurved Symptoms Raja varna N 46 Mean of Group A 1.89 Mean of Group B 2.31 S.D(+), B.T. 0.698 S.D(+), A.T. 0.582 S.E.(+), B.T. accept the null hypothesis H0 and reject the alternative hypothesis Ha, i.e. Pradarripu Rasa (Group A) is not significant than ShalmaliGhruta(Group B) for Rajaswaroopa. 0.134 Symptoms N Adhodarshool 53 S.E.(+), A.T. 0.133 Mean of Group A 1.542 U 172.5 Mean of Group B 1.828 U„ 340.5 S.D(+), B.T. 0.589 P <0.05 S.D(+), A.T. 0.658 S.E.(+), B.T. 0.12 S.E.(+), A.T. 0.122 U 268 U„ 428 P >0.05 As the p value is lower than the significance level alpha = 0.05, we should reject the null hypothesis H0 and accept the alternative hypothesis Ha, i.e. Pradarripu Rasa (Group A) is significant than ShalmaliGhruta(Group B) for Raja varna. As the p value is greater than the significance level alpha = 0.05, we should accept the null hypothesis H0 and reject the alternative hypothesis Ha, i.e. Pradarripu Rasa (Group A) is not significant than ShalmaliGhruta(Group B) for Adhodarshool. Symptoms Rajaswaroop N 51 Mean of Group A 1.63 Mean of Group B 1.375 S.D(+), B.T. 0.629 S.D(+), A.T. 0.494 Symptoms N Daurbalya 55 S.E.(+), B.T. 0.121 Mean of Group A 1.308 S.E.(+), A.T. 0.1 Mean of Group B 1.379 U 256.5 U„ S.D(+), B.T. 0.47 391.5 S.D(+), A.T. 0.493 >0.05 S.E.(+), B.T. 0.092 S.E.(+), A.T. 0.091 U 350 P As the p value is greater than the significance level alpha = 0.05, we should 6 *Special Issue for “National Seminar- Practical approach in Prasutitantra And Streerog 2015” ISBN 978-93-5173-179-3 ISSN 2320-7329 http://www.ayurlog.com Special issue*- 16th Feb. 2015 Vol. 3 Ayurlog: National Journal of Research in Ayurved Science A Web based quarterly online published Open Access peer reviewed National E-journal of Ayurved U„ 404 P >0.05 As the p value is greater than the significance level alpha = 0.05, we should accept the null hypothesis H0 and reject the alternative hypothesis Ha, i.ePradarripu Rasa (Group A) is not significant than ShalmaliGhruta(Group B) for Daurbalya. Symptoms Haemoglobin N 60 Mean Difference Score, Group A 0.273 Mean Difference Score, Group B 0.347 Combined S.D. (+) 0.31 S.E. (+) 0.08 Unpaired t 0.916 P <0.05 Result No Significant Difference As the t value calculated is lower than the t tabulated value at p=0.05, where df = 58, so there is no significant difference between the two groups. % RELIEF in OBSERVATIONS Sr. No. Parameter Group A Group B 1 Raja Kaal 77 % 58 % 2 Raja Praman 78 % 72 % 3 Raja Varna 80 % 70 % 4 Raja Swaroop 69 % 52 % 5 Adhodarshool 58 % 83 % 6 Daurbalya 60 % 71 % RESULT: In the present study, according collected data, it is observed that both the drugs i.e. Pradarripu Rasa and ShalmaliGhrutahas provided significant relief in all the symptoms of Raktapradar. The effect of treatment for the symptoms – Rajakala, Rajapramana , and Rajaswaroop of Raktapradar, Pradarripu Rasa (Group A) is significant than ShalmaliGhruta(Group B). But The effect of treatment for the symptoms – Adhoodarshool&Daurbalya of Raktapradar, ShalmaliGhruta(Group B) is significant than Pradarripu Rasa (Group A). There is no significant difference between the two groups for Haemoglobin. 7 *Special Issue for “National Seminar- Practical approach in Prasutitantra And Streerog 2015” ISBN 978-93-5173-179-3 http://www.ayurlog.com ISSN 2320-7329 Vol. 3 Special issue*- 16th Feb. 2015 Ayurlog: National Journal of Research in Ayurved Science A Web based quarterly online published Open Access peer reviewed National E-journal of Ayurved CONCLUSION Mode of action of drugs :In Raktapradar, excessive bleeding per vagina during menstrual cycle, prolonged menstrual bleeding, intermenstrual bleeding is observed along with abdominal pain ,daurbalyaetc which disturbs the normal life of female. In samprapti of Raktapradar we have seen that nidanasevan like Abhishyandi, vidahi, guru, amla, lavana, katurasatmakahara curd ,shukta, mastu, sura leads to pitta prakopa& ultimately raktadhushti also it aggrevates the vata which vitiates into garbhashayagatsira results in Raktapradar. Pradarripu Rasa is tikta-madhur-Kashay rasatmak7 drug having katuvipak and ushnavirya. Being laghu, ruksha causes Kaphashaman. Being tikta-madhur-kashay causes Pittashaman. It acts as pachak, Jathharagnivardhak,aamdoshnashak, saarak , balya, raktastambhak, vranaropak and purishsangrahak. Thus suppreses vitiated pitta &kapha. Relieves agnimandata and makes aaharrasaprakrut. Relieves rasagnivaishamya , makes prakrutaartava&rakta. With ushnaviryaand laghu- rukshaguna , relieves the increased dravaguna of rakta. Thus prakrutaartava&rakta reaches to garbhashaygatrajovahasira. With prakrutapanvayu controls the deerana( ExcessiveExcreation )of Raja. Thus cures the Raktapradar. In this way ,Pradarripu Rasa mainly acts on Pitta &Kapha . So markable results are observed on RajapravruttiKaal, RajapravruttiPramana ,Rajastrav Varna and Raja swaroop. ShalmaliGhrut a is madhur-tikta rasatmak8 drug having madhurvipak and sheetavirya. Being snigdha, guru, mrudu, pichhil causes mainly Vatashaman. Being madhurvipaki&sheetavirya causes Pittashaman. It acts as raktastambhak, daahprashamak, anulomak, grahi, deepan, balya, medhya, agnivardhak, aayubalavardhak, dhatu-ojavardhak and rasayan. Mainly suppresesvitiated Pitta &Vata. Relieves agnimandata and makes rasagniprakrut. Thus causes prakrutaartava&rakta. It also relieves apanvayudushti. Thus relieving pittavruttatva of apanvayu, causes prakrutdeerana (excreation) of rajaand thus cures Raktapradar. In this way, drug acts mainly on Pitta &Vata, so markable results are observed on adhodarshool&dourbalya. As total comparison of both Group drugs mentioned that Group A drug is quite effective than Group B drug. So more research in this work is necessary to bind firm conclusion about efficacy of drugs. ACKNOWLEDGEMENT. I am grateful to Shri. S. G. Deshmukh , Principle of CSMSS AyurvedMahavidhyalaya for providing all 8 *Special Issue for “National Seminar- Practical approach in Prasutitantra And Streerog 2015” ISBN 978-93-5173-179-3 http://www.ayurlog.com ISSN 2320-7329 Vol. 3 Special issue*- 16th Feb. 2015 Ayurlog: National Journal of Research in Ayurved Science A Web based quarterly online published Open Access peer reviewed National E-journal of Ayurved the facilities for research. I am also grateful to Jayshree S. Deshmukh for her guidance. I am also thankful to AjayThote for his help with statistics. REFERANCES 1. Ed. Vd. P.G.Aathvale, DrushtarthaSushrutChintan, Godavari Publishers, 1stEdition,Page 545. 2. Ed.PremvatiTiwari,Ayurvedicprasu titantraavamstreeroga , Part 2,Chaukhamba Sanskrit sansthan ,1stEdition,Page 204 3. Ed. Dr. D.C .Datta.,Textbook of Gynaecology, New central book agency, 5th edition, Page 183 4. Ed Vd. LuxmipatiShashtri, Yogratnakar,ChoukhambaPrakasha n, 5th Edition, Page 401 5. Ed Vd. LuxmipatiShashtri, Yogratnakar,ChoukhambaPrakasha n, 5th Edition, Page 400 6. Ed. Dr. B. K. Mahajan ,Biostatisics, Jaypee Publication, 6th edition. 7. Ed. P.S. Sharma, Database on Medicinal Plants used in Ayurveda, Central Council for Research in Ayurveda &sidhaVol – 2. 8. Ed. P.S. Sharma, Database on Medicinal Plants used in Ayurveda, Central Council for Research in Ayurveda &sidhaVol – 2. Cite this article: “A PROSPECTIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PRADARRIPU RASA IN COMPARISON WITH SHALMALI GHRUTA IN THE MANAGEMENT OF RAKTPRADAR.” NIKITA SAHEBRAO BADHIYA Ayurlog: National Journal of Research in Ayurved Science-2014; 2(4): 1-9 9 *Special Issue for “National Seminar- Practical approach in Prasutitantra And Streerog 2015”
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