A clinical trial to evaluate the efficacy and safety of CGA-7 on the Risk Factors of Obesity.

Phase 3

Active, not recruiting

• Conditions: Male and female overweight or obese subjects with BMI of 25-30 in the age group of 18-60 years

• Registration Number: CTRI/2017/04/008295
• Lead Sponsor: Vidya Herbs Pvt Ltd

Brief Summary

The trial is a prospective, randomized, double blind, parallel group, placebo controlled study to estimate the efficacy and safety of CGA-7 on the risk factors of obesity. The CGA-7 molecule was tested on rats that were fed with high fat diet to estimate its potential of anti-obesity property. After successful preclinical study, CGA-7 complex is now being investigated for its body fat loss effect in overweight and obese individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients who are willing to give written informed consent.
• Patient is willing and able to comply with all trial requirements 3.
• Overweight or obese; BMI between 25-30.

Exclusion Criteria

• Subjects with BMI >30 • Cigarette smoker, History of heart, liver and kidney disease, hypertension, pregnancy, lactating, Type 1 diabetes and weight loss medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reduction in body weight and BMI at week 4, 8 and 12 of treatment	1.Reduction in body weight and BMI at week 4, 8 and 12 of treatment | 2.Muscle mass-fat mass ratio, body fat (%) at visit 1 (Day 1) and final visit (12th week)
2.Muscle mass-fat mass ratio, body fat (%)	1.Reduction in body weight and BMI at week 4, 8 and 12 of treatment | 2.Muscle mass-fat mass ratio, body fat (%) at visit 1 (Day 1) and final visit (12th week)

Secondary Outcome Measures

Name	Time	Method
1.Changes in lipid profile (Triglycerides, cholesterol, HDL and LDL)	2.Blood pressure

Trial Locations

Locations (1)

Sri Kalabyraveswara Swamy Ayurvedic Medical College, Hospital and Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Sri Kalabyraveswara Swamy Ayurvedic Medical College, Hospital and Research Centre

🇮🇳Bangalore, KARNATAKA, India

Dr Kiran M Goud

Principal investigator

9845109556

skamcbangalore@gmail.com