Clinical trial to evaluate role of Tripada Guggul Vati as adjuvant treatment in Madhumeha Type2 DM

Phase 1

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2019/07/020141
• Lead Sponsor: I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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)

Exclusion Criteria

1.Known cases of TYPE-1 Diabetes Mellitus

2. Patients with any major systemic complications of DM.

3. Patients having any other major illness.

4. Known case of gestational diabetes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of an adjuvant effect of Tripada Guggul (Susrutokta) VatiTimepoint: 90 days

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>2.To evaluate the efficacy of drug on subjective parameters like kshudhavridhhi, pipasa, prabhutamutrata, Naktamutrata, Avil mutrata, hastapadtal daha, daurbalya, swedativrudhhi. <br/ ><br>3.To observe the effect of drug on body weight. <br/ ><br>4.To observe the effect of drug on B.M.I. <br/ ><br> <br/ ><br>Timepoint: HbA1cat day 0 and day 90, BSL-fasting/BSL-PP, urine sugar fasting and PP done monthly for 90 days. <br/ ><br>2.To evaluate the efficacy of drug on subjective parameters like kshudhavridhhi, pipasa, prabhutamutrata, Naktamutrata, Avil mutrata, hastapadtal daha, daurbalya, swedativrudhhi.