Journal of Research in Ayurvedic Sciences

Register      Login

VOLUME 1 , ISSUE 4 ( October-December, 2017 ) > List of Articles

RESEARCH ARTICLE

Selected Ayurvedic Formulations in Gynecological Disorders: A Clinical Safety and Pharmacoepidemiological Perspective

Aarti Sheetal

Keywords : Ashvagandha Churna, Clinical safety, Kanchnar Guggulu, Pravala Pishti, Rajahpravartini vati, Varunadi Kashaya,Ashokarishta

Citation Information : Sheetal A. Selected Ayurvedic Formulations in Gynecological Disorders: A Clinical Safety and Pharmacoepidemiological Perspective. J Res Ayurvedic Sci 2017; 1 (4):254-262.

DOI: 10.5005/jp-journals-10064-0026

License: CC BY-NC 3.0

Published Online: 00-12-2017

Copyright Statement:  Copyright © 2017; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Background: Nowadays, safety of a drug is a major challenge than its efficacy. As the demand for Ayurvedic drugs is increasing day by day, the reporting of safety is essential. Objective: To review the clinical safety of Ayurvedic formulations, viz., Rajahpravartini vati Kanchanara Guggulu, Varunadi Kashaya, Ashokarishta, Ashvagandha Churna, and Pravala Pishti, which were trialed in 3 clinical trials on women\'s health to assess their efficacy and also clinical safety. Materials and methods: The analyzed data of 03 clinical studies on Kastartava (dysmenorrhea), menopausal syndrome, and polycystic ovary syndrome (PCOS) were collected from the Central Council for Research in Ayurvedic Sciences (CCRAS) database. These studies were conducted at 9, 3, and 2 centers on 359, 115, and 60 cases respectively, at the CCRAS institutes. The data have been critically evaluated to assay the clinical safety of the named six drugs trialed in these studies. All the studies were approved by the Institutional Ethics Committee conducted following the guidelines of good clinical practice. Written consent was obtained from the participants before their enrolment. Safety assessments were done by analyzing the laboratory parameters like liver function test and kidney function test before and after the trial periods. Paired sample t-test was used to compare the mean score. Any adverse drug reactions (ADRs) and side effects were also critically monitored. Results: In all the studies, it is observed that the safety laboratory parameters were within the normal range after drug administration in the participants, who were from different age groups, habitats, and prakriti. No cases of any ADR or drug intolerability were reported during the treatment period. Conclusion: From the results, it may be concluded that all the trial drugs are safe to use and can be used for a long period. Clinical significance: The results of the present study support the notion that if any Ayurvedic formulation has been manufactured as per good manufacturing practices (GMP) and administered at the recommended dose and duration, it is safe for human use.


PDF Share
  1. Saha UC, Saha KB. A trend in women's health in India—what has been achieved and what can be done. Rural Remote Health 2010 Apr-Jun;10(2):1260.
  2. Victoria AV, Adlakha A. International Programs Center, U.S. Census Bureau, the Official Statistics™ 1998 10, December.
  3. Acharya JT. Charaka Samhita. 5th ed. Viman sathan, Adhyay 4. Varanasi: Chaukhamba Sasnkrit Sansthan; 2006. pp. 364-372.
  4. Sarmukaddam S, Chopra A, Tillu G. Efficacy and safety of Ayurvedic medicines: recommending equivalence trial design and proposing safety index. Int J Ayurveda Res 2010 Jul-Sep;1(3):175-180.
  5. Vagbhata. Ashtang Hridaya. 4th ed. Sutra Sathan. Adhyay 13. Varanasi: The Chaukhamba Sasnkrit Series office; 1970. p. 98.
  6. Anonymous. The Ayurvedic Formulary of India (AFI), Part I. 2nd ed., New Delhi: Ministry of Health and Family Welfare, Govt. of India, The Controller of Publications; 2003. p. 192.
  7. Anonymous. The Ayurvedic Formulary of India (AFI), Part I. 2nd ed., New Delhi: Ministry of Health and Family Welfare, Govt. of India, The Controller of Publications; 2003. p. 67.
  8. Sahashtra Yoga. Pratham Prakran-Kashaya Yoga. Central Council of Research for Ayurvedic Sciences; 2011(Reprinted). 95p (472).
  9. Anonymous. The Ayurvedic Pharmacopeia of India (API), Part I. 2nd ed. New Delhi: Ministry of Health and Family Welfare, Govt. of India, The Controller of Publications; 2007. pp. 10-12.
  10. Anonymous. The Ayurvedic Pharmacopeia of India (API), Part I. 2nd ed. New Delhi: Ministry of Health and Family Welfare, Govt. of India, The Controller of Publications; 2007. pp. 19-20.
  11. Anonymous. The Ayurvedic Formulary of India (AFI), Part I. 2nd ed., New Delhi: Ministry of Health and Family Welfare, Govt. of India, The Controller of Publications; 2003. p. 223.
  12. Tomar R, Sharma S, Kumari I, Gangurde V, Ota S, Dua P, Khanduri S, Yadav B, Rana R, Singhal R, et al. Efficacy of Ashokarishta, Ashvagandha churna and Pravala pishti in the management of Menopausal syndrome—a prospective multi-centric clinical study. J Res Ayurvedic Sci 2017 Jan- Mar;1(1):9-16.
  13. Sarada O, Kanchnara D, Madhavi K, Dhiman K. The management of primary dysmenorrhoea (Kashtartava)—a prospective multicentric open observational study. Int J Ayurveda Pharma Res 2015 July;3(7):7-14.
  14. World health Organization. 2017. Available from: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/ pharmvigi/en/
  15. Manjunath A, Shradda N, Prasad BS, Kadam A. Adverse drug reaction and concepts of drug safety in Ayurveda: an overview. J Young Pharm 2013;5(4):116-120, p. 5.
  16. Acharya JT. Charaka Samhita. 5th ed. Viman Sathan, Adhyay 8. Varanasi: Chaukhamba Sasnkrit Sansthan; 2006. p. 276.
  17. Acharya JT. Charaka Samhita. 5th ed. Viman Sathan, Adhyay 4. Varanasi: Chaukhamba Sasnkrit Sansthan; 2006. p. 247.
  18. Acharya JT. Charaka Samhita. 5th ed. Sutra Sathan, Adhyay 11. Varanasi: Chaukhamba Sasnkrit Sansthan; 2006. p. 58.
  19. Sastri Ambikadutt. Sushrut Samhita. 6th ed. Sutra Sathan, Adhyay 10. Varanasi: Chaukhamba Sasnkrit Sansthan; 1987. p. 31.
  20. Shastri Laxmipati. Yoga Ratnakar. 7th ed. Vidyotini Hindi commentry, edited by Brahmashankar Shastri. Varanasi: Chaukhambha Sanskriti Samsthana; 1999. p. 5.
  21. Sastri Ambikadutt. Sushrut Samhita. 6th ed. Sutra Sathan, Adhyay 39. Varanasi: Chaukhamba Sasnkrit Sansthan; 1987. p. 148.
  22. Kruth P, Brosi E, Fux R, Morike K, Gleiter CH. Gingerassociated over anticoagulation by phenpocoumon. Ann Pharmacother 2004 Feb;38(2):257-260.
  23. Pyevich D, Bogenschute MP. Herbal diuretics and lithium toxicity. Am J Psychiatry 2001 Aug;158(8):1329.
  24. Dandekar UP, Chandra RS, Dalvi SS. Analysis of a clinically important interaction between phenytoin and sankhpushphi, an Ayurvedic preparation. J Ethnopharmacol 1992 Jan;35(3):285-288.
  25. Kasinath Shastri, Sadanand S. Rasatarangini. 11th ed. Motilal banarsidas. pp. 52-58.
  26. Gholkar MS, Mulik MB, Laddha KS. Fate of β-asarone in Ayurvedic Sodhana process of Vacha. J Ayurveda Integr Med 2013 Jan-Mar;4(1):19-22.
  27. Nabar MP, Mhaske PN, Pimpalgaonkar PB, Laddha KS. Gloriosa superba roots: content change of colchicines during sodhana (detoxification) process. Indian J Tradit Knowl 2013 April;12(2):277-280.
  28. Manasi N, Pimpalgaonkar PB, Laddha KS. Studies on Shodhana prakriya of Gunja (Abrus precatorius Linn.) seeds. Indian J Tradit Knowl 2011 October;10(4):693-696.
  29. Mishra Vd. Gulraj Sharma, Ayurved Prakash, Varanasi: The Chaukhamba Vidya Bhawan; 1962. p. 325.
  30. Anonymous. The Ayurvedic Formulary of India (AFI), Part I. 2nd ed., New Delhi: Ministry of Health and Family Welfare, Govt. of India, The Controller of Publications; 2003. p. 65.
  31. Acharya JT. Charaka Samhita. 5th ed. Sutra sathan. Varanasi: Chaukhamba Sasnkrit Sansthan; p. 23.
PDF Share