{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:45:25Z","timestamp":1785545125689,"version":"3.56.0"},"reference-count":32,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n \n In Ayurveda,\n Prameha<\/jats:italic>\n (diabetes mellitus) is considered\n Ashtamahagada Vyadhi<\/jats:italic>\n (one among eight diseases difficult to treat and cure).\n Tridosha<\/jats:italic>\n (three bio-humor in Ayurveda) with certain metabolic factors are involved in its pathogenesis. Frequent urination is a common symptom of this disease. Diabetes mellitus can be confused with type 2 diabetes mellitus in conventional science due to the resemblance in cardinal features.\n <\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n \n The primary objectives of this pilot study are to assess feasibility through recruitment, retention, adherence, data completeness, and participant acceptability. It also aims to estimate variability in outcome measures like fasting blood sugar and glycated hemoglobin (HbA\n 1c<\/jats:sub>\n ). The secondary, exploratory objective is to observe trends in these clinical indicators to inform effect size assumptions for future trials.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n In this pilot study 36 individuals with type 2 diabetes mellitus will be recruited and split into two equal groups at random. In Group A (Control), metformin tablets (500 mg) will be prescribed daily once before lunch with plain water for 45 consecutive days. In Group B (Interventional group), the\n Nimba-Amalakyadi<\/jats:italic>\n formulation will be prescribed 5 grams twice daily with an empty stomach (ie, 7 AM-5 PM) with lukewarm water for 45 consecutive days. Follow-up will be taken on days 45 and 90 to study the sustained effect of the drug.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The preliminary analysis of participant responses began in January 2025. Final results from this phase are expected to be available by June 2025. Recruitment rate (number recruited\/month), eligibility rate (number eligible\/number screened), retention rate at 45 days, compliance with intervention (percentage of prescribed doses taken), adherence to follow-up investigations, acceptability of intervention (based on participant-reported feedback), and data completeness rates are variables. Moreover, changes in the objective parameters, ie, reductions in blood sugar level (fasting and postprandial) and HbA\n 1c<\/jats:sub>\n values of patients will be also observed and recorded.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n A conclusion will be drawn according to the clinical findings obtained at baseline and follow-up visits with biochemical reports of the patients. The trial will prove the feasibility and comparative efficacy of\n Nimba Amalakyadi<\/jats:italic>\n formulation versus metformin tablets for the management of type 2 diabetes mellitus\n .<\/jats:italic>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/63574","type":"journal-article","created":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T22:05:06Z","timestamp":1757541906000},"page":"e63574-e63574","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of the Comparative Efficacy of an Ayurvedic Formulation (Nimba-Amalakyadi Powder) vs Metformin in the Management of Type 2 Diabetes Mellitus: Protocol for a Pilot Study"],"prefix":"10.2196","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7980-7832","authenticated-orcid":false,"given":"Punam","family":"Sawarkar","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5605-795X","authenticated-orcid":false,"given":"Gaurav 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