{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T14:54:39Z","timestamp":1785855279306,"version":"3.56.0"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"vor","delay-in-days":16,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Current Protocols"],"published-print":{"date-parts":[[2026,7]]},"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:bold>\n : Diabetes mellitus is a major and growing contributor to morbidity and mortality. Indian Council of Medical Research\u2013India Diabetes study reports a prevalence of 11.4% for diabetes and 15.3% for prediabetes in India. Diabetes is described in depth in ancient Ayurveda texts, from aetiology to pre\u2010clinical, clinical features, complications, and its stage\u2010wise management. The current study has the potential to explore whether lowering glycemic control at the level of haemoglobin affects endogenous insulin production by examining C\u2010peptide and insulin levels.\n <\/jats:p>\n \n Methods<\/jats:bold>\n : The current study is designed as a randomized, double\u2010blind, placebo\u2010controlled, multicenter, two\u2010arm clinical trial enrolling 220 participants across two Indian sites. Adults with diagnosed Type\u20102 diabetes mellitus on oral hypoglycemic agents (OHAs) with glycated haemoglobin (HbA1c) between 8% and 10% will be randomized (1:1) to receive either an Ayurvedic Formulation,\n Varadi Kwath Ghana Vati<\/jats:italic>\n , or a matched placebo, administered twice daily after meals as an adjunct to standard OHAs therapy for 180 days. The primary outcome is the mean change in HbA1c from baseline to 90 and 180 days. Secondary outcomes include the proportion of participants achieving optimal glycemic control, i.e., HbA1c \u22647%; changes in fasting C\u2010peptide, fasting insulin, lipid profile, liver function tests, and renal function tests at baseline, 90, and 180 days. Treatment effects will be estimated as between\u2010group differences in mean changes \u00b1 standard deviation (\n SD)<\/jats:italic>\n , reported with 95% confidence intervals, with statistical significance set at\n p<\/jats:italic>\n \u00a0<\u00a0.05.\n <\/jats:p>\n \n Discussion<\/jats:bold>\n : Following the lead from the classical anti\u2010diabetic action of\n Varadi Kwath<\/jats:italic>\n ingredients, i.e.,\n Haritaki<\/jats:italic>\n (\n Terminalia chebula<\/jats:italic>\n Retz),\n Bibhitaki<\/jats:italic>\n [\n Terminalia bellirica<\/jats:italic>\n (Gaertn.) Roxb.],\n Amalaki<\/jats:italic>\n (\n Phyllanthus emblica<\/jats:italic>\n L.),\n Daruharidra<\/jats:italic>\n (\n Berberis aristata<\/jats:italic>\n DC.),\n Musta<\/jats:italic>\n (\n Cyperus rotundus<\/jats:italic>\n L.), and\n Devdaru<\/jats:italic>\n (\n Cedrus deodara<\/jats:italic>\n Roxb. Ex D.Don). The drug will be evaluated through HbA1c and the indigenous production of C\u2010peptide and insulin through the study.\n <\/jats:p>\n \n Trial registration<\/jats:bold>\n : CTRI\/2026\/01\/100208, Registered on: 02\/01\/2026, Registered Prospectively. \u00a9 2026 Wiley Periodicals LLC.\n <\/jats:p>","DOI":"10.1002\/cpz1.70423","type":"journal-article","created":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T16:06:34Z","timestamp":1784304394000},"source":"Crossref","is-referenced-by-count":0,"title":["A Randomized Double\u2010Blind Placebo\u2010Controlled Multicentric Clinical Trial of an Ayurvedic Intervention,\n Varadi Kwatha Ghana Vati<\/i>\n , as an Adjunct vs Treatment as Usual in the Management of Type\u20102 Diabetes Mellitus: A Study Protocol"],"prefix":"10.1002","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6557-1221","authenticated-orcid":false,"given":"Suhas","family":"Chaudhary","sequence":"first","affiliation":[{"name":"Research Officer (Ayurveda), M.S. Regional Ayurveda Research Institute Central Council for Research in Ayurvedic Sciences (CCRAS) Jaipur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeuti Rani","family":"Das","sequence":"additional","affiliation":[{"name":"Research Officer (Ayurveda), Central Ayurveda Research Institute Central Council for Research in Ayurvedic Sciences (CCRAS) Guwahati India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kishor","family":"Gavali","sequence":"additional","affiliation":[{"name":"Research Officer (Ayurveda), M.S. Regional Ayurveda Research Institute Central Council for Research in Ayurvedic Sciences (CCRAS) Jaipur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Avinash Kumar","family":"Jain","sequence":"additional","affiliation":[{"name":"Research Officer (Ayurveda), M.S. Regional Ayurveda Research Institute Central Council for Research in Ayurvedic Sciences (CCRAS) Jaipur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Girindra","family":"Bora","sequence":"additional","affiliation":[{"name":"Research Officer (Bio\u2010chem), Central Ayurveda Research Institute Central Council for Research in Ayurvedic Sciences (CCRAS) Guwahati India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P. L.","family":"Bharati","sequence":"additional","affiliation":[{"name":"Research Officer (Ayurveda), Central Ayurveda Research Institute Central Council for Research in Ayurvedic Sciences (CCRAS) Guwahati India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Varsha","family":"Sumedhan","sequence":"additional","affiliation":[{"name":"Research Officer (Ayurveda) Central Council for Research in Ayurvedic Sciences (CCRAS) Headquarters New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B. S.","family":"Sharma","sequence":"additional","affiliation":[{"name":"Research Officer (Ayurveda) Central Council for Research in Ayurvedic Sciences (CCRAS) Headquarters New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B. C. S.","family":"Rao","sequence":"additional","affiliation":[{"name":"Retired Assistant Director (Ayurveda) Central Council for Research in Ayurvedic Sciences (CCRAS)Headquarters New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Maheswar","sequence":"additional","affiliation":[{"name":"Assistant Director (Ayurveda) Central Council for Research in Ayurvedic Sciences (CCRAS) Headquarters New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Srikanth","sequence":"additional","affiliation":[{"name":"Deputy Director General Central Council for Research in Ayurvedic Sciences (CCRAS) New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,17]]},"reference":[{"key":"e_1_2_15_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc11\u2010S003"},{"issue":"1","key":"e_1_2_15_3_1","first-page":"S1","article-title":"Introduction: Standards of medical care in diabetes\u20142018","volume":"41","author":"American Diabetes Association","year":"2018","journal-title":"Diabetes Care"},{"key":"e_1_2_15_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213\u20108587(23)00119\u20105"},{"key":"e_1_2_15_5_1","first-page":"145","article-title":"Type 2 diabetes: Postprandial hyperglycaemia and increased cardiovascular risk","volume":"6","author":"Aryangat A. 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