A clinical study to compare the effects of Yavanyadi and Nishakathakadi tablets as an add-on medication in patients with Type 2 Diabetes mellitus.
Phase 3
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/07/069893
- Lead Sponsor
- Dr Deepika GI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.participants of age group 25-75 years 2.HbA1c greater than 6.5% 3.FBS level from 126mg/dl -250mg/dl or PPBS level from 200mg/dl-400mg/dl 4.Under stable dose of an anti-diabetic therapy.
Exclusion Criteria
1.HbA1c greater than 9.5% 2.Diagnosed cases of morbid cardiac & pulmonary HTN, metabolic complications like hyper-osmolar state 3. Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in blood parameters <br/ ><br>1. FBS <br/ ><br>2. PPBS <br/ ><br>3. HbA1cTimepoint: Baseline,4weeks, 8weeks, 12weeks
- Secondary Outcome Measures
Name Time Method 1.For Standardization of the study drug physical parameters like Ash value, extractive value,TLC 2. Changes in Blood parameters of LFT, RFT 3.BMI <br/ ><br> <br/ ><br>Timepoint: Baseline and 90th day