Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Clinical Trials Registry - India
Year
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2019
INTERVENTION: Intervention1: Tripada Guggul Vati (500mg Rasayan kal and Pragbhat kal)morning and evening empty stomach as an adjuvant treatment with OHA (metformin as prescribed): Subjects in trial group who will be administered Tripada Guggul Vati (500mg Rasayan kal and Pragbhat kal) morning and evening empty stomach as an adjuvant treatment with OHA metformin as prescribed Control Intervention1: OHA metformin (500mg BD as prescribed): OHA (metformin twice daily as prescribed ) CONDITION: Type 2 diabetes mellitus without complications PRIMARY OUTCOME: To evaluate the efficacy of an adjuvant effect of Tripada Guggul (Susrutokta) VatiTimepoint: 90 days SECONDARY OUTCOME: 1.To evaluate the efficacy of drug in achieving glycaemic control on the basis of HbA1c , BSL‐fasting , BSL‐post prandial state, urine sugar fasting and post prandial. ; 2.To evaluate the efficacy of drug on subjective parameters like kshudhavridhhi, pipasa, prabhutamutrata, Naktamutrata, Avil mutrata, hastapadtal daha, daurbalya, swedativrudhhi. ; 3.To observe the effect of drug on body weight. ; 4.To observe the effect of drug on B.M.I. ; ; Timepoint: HbA1cat day 0 and day 90, BSL‐fasting/BSL‐PP, urine sugar fasting and PP done monthly for 90 days. ; 2.To evaluate the efficacy of drug on subjective parameters like kshudhavridhhi, pipasa, prabhutamutrata, Naktamutrata, Avil mutrata, hastapadtal daha, daurbalya, swedativrudhhi. INCLUSION CRITERIA: 1. Patients with Signs & Symptoms of Madhumeha (hastapadtaladaha, pipasa, kshudhavridhhi, prabhutmootrata, avilmootrata, naktamootrata, Daurbalya, swedativrudhhi) 2. Age : 25 years to 60 years of either gender. 3. K/C/O Type 2 Diabetes Mellitus from 1‐ 5 years 4. BSL ‐ F >126 mg/dl & BSL‐PP > 200 mg/dl up to 300mg/dl 5. HbA1c â?? <10 % ( showing good , fair, moderate control)
Epistemonikos ID: 237a2feb840777bebbd8e79546ca345ea512f453
First added on: Dec 20, 2022