A clinical trial to study effects of Rasapachaka Kashaya on overweight Prediabetic persons.
Phase 2
- Conditions
- Health Condition 1: R730- Abnormal glucose
- Registration Number
- CTRI/2024/05/066621
- Lead Sponsor
- Government Ayurvedic College and Hospital Nanded
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients with FPG:100-125mg/dL and HbA1c: 5.7-6.4% without any medication.
2. Age group 30-60 yrs.
3. Patients will be selected irrespective of their sex, religion, geographical areas and economical condition.
Exclusion Criteria
1. Patients with history of other diseases leading to DM (Autoimmune, Secondary to other diseases or condition).
2.Pregnant and lactating women.
3.Other major systemic disorders with complication.
4. Patients on steroidal intake for any other major systemic diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the insulin resistance (HOMA-IR) value to be calculated with fasting glucose(mg/dl) ,fasting insulin levels(mu/L) and the HbA1c(%) values.Timepoint: 0 and 91st days for objective criterias.
- Secondary Outcome Measures
Name Time Method 1. To assess effect of Rasapachaka Kashaya on Fasting Plasma Glucose, HbA1c. <br/ ><br>2. To assess the effect of Rasapachaka Kashaya on Insulin Resistance (Calculated with HOMA IR) <br/ ><br>3. To study role of Rasapachaka Kashaya on Daurbalya, Atikshudha, Atitrushna. <br/ ><br>4. To asses side effects of drug if any. <br/ ><br>5. To assess the effect of Rasapachaka Kashaya in comparison with Rukshaniya Dravya Churna (3gm each with Koshna Jala)Timepoint: Fasting Plasma Glucose, HbA1c, Insulin Resistance (HOMA IR) on 0 and 91st days. <br/ ><br>Daurbalya, Atikshudha, Atitrushna on 0, 30, 60, 91st days and follow up assessment on 150 days.