A clinical trial to study the effects of Ayurveda drugs in Type 2 Diabetes Mellitus patients
Phase 3
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/05/067407
- Lead Sponsor
- Dr Archana Daundkar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age 30 to 60 years
Sex either
Newly diagnosed Patients having signs and symptoms of Prameha w.s.r to Type 2 Diabetes Mellitus
Patients having F BSL-126 to 164 mg/dl PPBSL-140 to180 mg/dl and HbA1c 6.5% to 8%
BMI in between 23-45 kg/m2
Patients having stable dose of metformin for whole trial period.
Exclusion Criteria
Known patient of Type 1 DM
Patients on insulin or oral steroid treatment.
Patients with other known systemic disorders
Patient with known micro /macrovascular complications related to Diabetes such as CKD, Renal parenchymal Disease, Hepatic Dysfunction.
Pregnant women and lactating Mothers.
Patients unable to provide written informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To observe the changes in glycemic parametersTimepoint: 90 DAYS
- Secondary Outcome Measures
Name Time Method To assess effect on BMI and Waist circumferenceTimepoint: 90 DAYS;To assess the effect of drug on sign and symptoms.Timepoint: 90 DAYS;To assess the side effects if anyTimepoint: 90 DAYS;To observe the changes in glycemic parametersTimepoint: 90 DAYS;To observe the changes in subjects Quality of Life by EQ5D QuestionnaireTimepoint: 90 DAYS