A clinical trial to evaluate efficacy and safety of CGA-7 complex capsules in reducing the bodyweight in obese patients
- Conditions
- Health Condition 1: E668- Other obesity
- Registration Number
- CTRI/2013/10/004096
- Lead Sponsor
- VIdya Herbs
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
•Age between 18 and 60 years.
•Able to sign voluntarily informed consent.
•Obese subjects with Body mass index 30 to 40kg/m2
•Obese subjects with Waist circumference > 40 inches/102 cm in male, > 35 inches/88 cm in female
•Subjects must understand risks and benefits of the protocol
•In Lipid profile, Total cholesterol In Lipid profile, Total cholesterol >= 200, LDL level >= 150, HDL level <= 55 in both men & women, HbA1C <= 6%, Fasting blood glucose level < 100 and Fasting insulin level <= 7 µU/ml.
•Diet should be maintained.
•Willingness to participate in the exercise walking program
•Willingness to participate in 06 clinical visits (Screening, Day 1, Day 14, Day 28, Day 56 and Day 70).
•If female, should be negative in pregnancy test. Female of child bearing potential, should agree to follow an acceptable method of birth control for the duration of the study.
•Have a history of hypertension, Angina, stroke, thyroid diseases
•Any other clinically significant disorder
•Non-obese (BMI <30) & morbidity obese ( >40).
•Presently using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss
•Recent, unexplained weight loss or gain
•History of HIV positive patients
•History of hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis.
•History of motor weakness or peripheral sensory neuropathy
•Have orthopedic joint problems that would be barrier to physical activity such as walking.
•Are currently participating in any weight loss clinical trial.
•Women who are pregnant and nursing mothers
•People with major psychiatric illness
•Any contraindication to blood sampling
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Reduction in body weight and BMITimepoint: â?¢At Screening ,day 14,day 28 and day 56
- Secondary Outcome Measures
Name Time Method â?¢Changes in lipid profile <br/ ><br>â?¢Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction <br/ ><br>â?¢Quality of life of the subjects (SF-36) <br/ ><br>â?¢Hb1Ac concentration <br/ ><br> â?¢Incidence and rate of adverse eventsTimepoint: At baseline and week 8