A clinical trial to assess safety and efficacy of new formulation (NIA/DG-04) in Type 2 Diabetes Mellitus
Phase 2
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/03/041358
- Lead Sponsor
- ational Institute Of Ayurveda Jaipur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients in the age group of 30-60 years.
2. Patients with Fasting Blood Sugar (FBS) above 126 mg/dl, Post Prandial Blood Sugar (PPBS) above 140 mg/dl.
3. Type 2 Diabetes Mellitus
4. Presence of cardinal symptoms of Madhumeha as described in Ayurvedic texts.
Exclusion Criteria
1. Patients of Type 1 Diabetes Mellitus
2. Patients of Type 2 Diabetes Mellitus who are on insulin therapy.
3. Patients having any serious illness like coronary artery disease, malignancy, kidney failure, and diabetic complications like neuropathy etc.
4. Impaired values of LFT, RFT
5. Pregnant women and lactating mother.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Blood glucose level (Fasting and Post Prandial)Timepoint: 30 days
- Secondary Outcome Measures
Name Time Method Changes in Madhumeha lakshana scoring, changes in Triglyceride, HDL and LDL cholesterol level, BMI.Timepoint: 30 days