Health Condition 1: E668- Other obesity
Conditions
Interventions
Intervention1: CGA-7 complex Capsules: Three times a day before breakfast,lunch and dinner for 2 months taken orally
Control Intervention1: Placebo: Three times a day before breakfast, lunch and dinne
Sponsors
VIdya Herbs
Eligibility
Inclusion criteria
Inclusion criteria: • 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 • 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.
Exclusion criteria
Exclusion criteria: • Have a history of hypertension, Angina, stroke, thyroid diseases • Any other clinically significant disorder • Non-obese (BMI 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Reduction in body weight and BMITimepoint: â?¢At Screening ,day 14,day 28 and day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Changes in lipid profile â?¢Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction â?¢Quality of life of the subjects (SF-36) â?¢Hb1Ac concentration â?¢Incidence and rate of adverse eventsTimepoint: At baseline and week 8 | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBio Clinical research Pvt Ltd
Outcome results
None listed