To observe the effect of Ayurvedic medicine for the treatment of Obesity with abnormal lipid profile

Phase 2

• Conditions: Health Condition 1: E889- Metabolic disorder, unspecified

• Registration Number: CTRI/2022/01/039315
• Lead Sponsor: Desh Bhagat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

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

Inclusion Criteria

Male and Female 18-65 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference > 102 cm (M) or >88 cm (F), and two or more of these criteria:

1. fasting blood glucose >100 mg;

2. systolic blood pressure >135 or diastolic blood pressure >85 mmHg

3. triglyceridemia >150 mg/dl;

4. HDL cholesterolemia < 40 mg/dl (M), < 50 mg/dl(F).

5. Patient willing to participate in the study for 12 weeks.

Exclusion Criteria

1. Patients with diabetes mellitus (FBS >126mg/dl);

2. Patients with blood pressure more than 160/100 mmHg.

3. Triglyceridemia > 500 mg/dl;

4. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders etc).

5. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia.

6. Symptomatic patients with clinical evidence of heart failure, hepatic failure and renal failure (serum creatinine >2 mg/dl).

7. Alcoholics and/or drug abusers.

8. Pregnant and lactating mothers

9. Any other condition which the Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in waist circumference (WC) <br/ ><br>Change in Body Mass Index (BMI) <br/ ><br>Change in Insulin Resistance using Homeostatic model assessment (HOMA-IR) index <br/ ><br>Change in Insulin Resistance using quantitative insulin sensitivity check index (QUICKI) <br/ ><br>Timepoint: 3 months

Secondary Outcome Measures

Name	Time	Method
Change in lipid profile <br/ ><br>Change in systolic and diastolic blood pressure <br/ ><br>Change in blood glucose and insulin level <br/ ><br>Change in Renal function & liver function <br/ ><br>Timepoint: 3 months