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Journal of Research in Ayurvedic Sciences 2017 July- September ; 1 (3) :136-141
Clinical Safety of Selected Ayurvedic Formulations in Management of Irritable Bowel Syndrome
Renu Singh (1), Renu Singh (1), Punendu Panda (2), Punendu Panda (2), Laxman W Burke (3), Laxman W Burke (3), Harbans Singh (4), Harbans Singh (4), Surendra K Sharma (5), Surendra K Sharma (5), Krishna Kumari (6), Krishna Kumari (6), Om Raj Sharma (7), Om Raj Sharma (7), Meda M Rao (8), Meda M Rao (8), Rinku Tomar (9), Rinku Tomar (9), Shweta Chaudhary (10), Shweta Chaudhary (10), Shruti Khanduri (1), Shruti Khanduri (1), Gurucharan Bhuyan (11), Gurucharan Bhuyan (11), Babita Yadav (1), Babita Yadav (1), Pradeep Dua (12), Pradeep Dua (12), Rakesh K Rana (13), Rakesh K Rana (13), Richa Singhal (14), Richa Singhal (14), Adarsh Kumar (15), Adarsh Kumar (15)
1. Research Officer (Ayurveda),Central Council for Research in Ayurvedic Sciences New Delhi, India 2. Research Officer (Ayurveda), National Research Institute of Ayurvedic Drug Development Bhubaneswar, Odisha, India 3. Research Officer (Ayurveda),Regional Ayurveda Research Institute for Urinary Disorders Jammu, Jammu and Kashmir, India 4. Research Officer (Ayurveda),Central Ayurveda Research Institute for Respiratory Disorders Patiala, Punjab, India 5. Assistant Director (Ayurveda), Regional Ayurveda Research Institute for Nutritional Disorders, Mandi, Himachal Pradesh, India 6. Assistant Director (Ayurveda),Regional Ayurveda Research Institute for Urinary Disorders Jammu, Jammu and Kashmir, India 7. Former Assistant Director (Ayurveda), Regional Ayurveda Research Institute for Nutritional Disorders, Mandi, Himachal Pradesh, India 8. Central Ayurveda Research Institute for Hepatobiliary Disorders, Bhubaneswar, Odisha, India 9. Research Officer (Ayurveda), Regional Ayurveda Research Institute for Mother and Child Health, Nagpur, Maharashtra, India 10. Research Officer (Ayurveda),Central Council for Research in Ayurvedic Sciences New Delhi, India 11. Research Officer (Ayurveda),Central Ayurveda Research Institute for Hepatobiliary Disorders, Bhubaneswar, Odisha, India 12. Research Officer (Ayurveda), Central Council for Research in Ayurvedic Sciences New Delhi, India 13. Statistical Officer (Ayurveda),Central Council for Research in Ayurvedic Sciences New Delhi, India 14. Statistical Assistant (Ayurveda), Central Council for Research in Ayurvedic Sciences New Delhi, India 15. Assistant Director (Ayurveda),Central Council for Research in Ayurvedic Sciences New Delhi, India
Abstract
Introduction: Irritable bowel syndrome (IBS) is a part of the larger group of functional gastrointestinal (GI) disorders that despite differences in location and symptom patterns share common features with regard to their motor and sensory physiology and central nervous system relationships. It generates a significant health care burden and can severely impair quality of life. It is characterized by symptoms of abdominal pain and discomfort that is associated with disturbed defecation. Ayurveda compares the symptoms of IBS with some of the diseases like Grahani, Kaphaja Pravahika, Shokaja Atisara, Bhayaja Atisara, etc. Bilvadi Leha and Kutajarishta are two common Ayurvedic formulations that are currently used for the management of such diseases. However, the safety of these drugs was not evaluated until now. Objective: Analysis of clinical safety and efficacy outcomes of Bilvadi Leha and Kutajarishta in IBS generated through multicenter open-label clinical studies at different CCRAS centers. Materials and methods: Analysis of data collected from two different clinical studies was critically evaluated. Safety assessments were done through analyzing liver function tests (LFTs), alanine aminotransferase, aspartate aminotransferase, serum alkaline phosphatase, serum protein, albumin, globulin, and bilirubin, and kidney function tests (KFTs) before and after the trial period. Paired sample t-test was used for comparison A p-value <0.05 was considered significant. Drug compliance and adverse drug reaction/adverse events, if any, were noted. Conclusion: The analysis of two different clinical studies clearly reveals that Bilvadi Leha and Kutajarishta are clinically safe, effective, and tolerable. Keywords: Bhayaja Atisara, Bilvadi Leha, Grahani, Kaphaja Pravahika, Kutajarishta, Shokaja Atisara.
DHARA ID: D059568
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