A Prospective, Randomized, Double blind, Placebo controlled clinical trial to evaluate efficacy and safety of CGA-7 complex capsules in reducing the bodyweight in obese patients

VIdya Herbs0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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 ÂµU/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

发起方