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A multicenter clinical trial on the anti-diabetic efficacy and safety profile of Saptavimshatika Guggulu and Haridra Churna in the management of type 2 diabetes mellitus
Avinash K Jain1, Surinder K Sharma2, Dipsundar Sahu3, Vinod B Kumawat4, Om R Sharma2, Pradeep Dua5, Babita Yadav1, Shruti Khanduri1, Sarada Ota1, Gurucharan Bhuyan6, Rakesh Rana1, Richa Singhal1, Bharti Gupta7, Madan M Padhi1, Kartar S Dhiman1
1 Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India
2 Regional Ayurveda Research Institute for Nutritional Disorders, Mandi, Himachal Pradesh, India
3 Central Ayurveda Research Institute for Drug Development, Kolkata, West Bengal, India
4 Regional Ayurveda Research Institute for Drug Development, Gwalior, Madhya Pradesh, India
5 Bureau of Indian Standard Hqrs., New Delhi, India
6 Central Ayurveda Research Institute for Hepatobiliary Disorders, Bhubaneswar, Odisha, India
7 Central Ayurveda Research Institute for Cardiovascular Disorders, New Delhi, India
Correspondence Address:
Dr. Avinash K Jain
Research Officer, Central Council for Research in Ayurvedic Sciences (CCRAS), 61–65, opp. D' Block, Janakpuri Institutional Area, Janakpuri, New Delhi 110058
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jras.jras_40_21
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BACKGROUND: Madhumeha (diabetes mellitus [DM]) disease is one of the very few diseases, which has been found in the history and culture of India and across the globe. Since ages, even in the twenty-first century, this disease is a cause of concern to the world due to its morbidity and long-term complications. Traditional medicines are still found to be very useful in the improvement of quality of life (QOL) of the patients with Madhumeha. Ayurvedic formulations are found to be useful in the management of type II DM and in promoting health. OBJECTIVE: Saptavimshatika Guggulu (SG) and Haridra Churna (HC) were evaluated to assess their clinical effectiveness in the management of type 2 diabetes. A secondary objective was to assess the changes in the QOL of the patients with type 2 DM and the clinical safety of SG and HC. MATERIALS AND METHODS: This multicenter clinical study was critically evaluated to assay the clinical efficacy and safety profile of ayurvedic formulations, SG 500 g two tablets two times after food and HC 3 g with luke-warm water after food two times daily for 12 weeks in 146 participants, diagnosed with NIIDM, enrolled as per the selection criteria. RESULTS: The results were of highly significant in the regulation of FBS (BT-167.44 mg/dL, AT-152.83 mg/dL) and PPBS (BT-261.74 mg/dL, AT-240.59 mg/dL). Statistically highly significant result was found in the improvement of Diabetes Symptoms Questionnaire and SF-36 health survey score; no ADR or any complications were noted. CONCLUSION: SG and HC used on the subjects of type 2 DM (Madhumeha) are clinically effective, safe, and tolerable. |
