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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- VIdya Herbs
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- •Reduction in body weight and BMI
研究概览
简要总结
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
Primary objectives:
· To evaluate the safety and efficacy of CGA-7 complex treating obesity in obese patients
Secondary objectives:
To evaluate the safety and role of CGA-7 complex in improving the quality of life of the subjects
Primary outcomes
· Reduction in body weight and BMI at Day 14, Day 28, Day 56 from Screening
Secondary outcomes
· Changes in lipid profile (Screening and Day 56(EOT))
· Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction (Day 1 and Day 56(EOT))
· Quality of life of the subjects (SF-36) (Day 1 and Day 56(EOT))
· Hb1Ac concentration (Screening and Day 56(EOT))
Incidence and rate of adverse events
The drug which is been used in the study is a composition of an herbal product called Coffee bean extract. CGA-7 complex is a Coffee bean extract. CGA-7 is a 100% natural extract from Green coffeebeans , which contains chlorogenic acids rich PolyPhenols
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Age between 18 and 60 years.
- •â€¢Able to sign voluntarily informed consent.
- •â€¢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.
- •â€¢Diet should be maintained.
- •â€¢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).
- •â€¢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.
排除标准
- •â€¢Have a history of hypertension, Angina, stroke, thyroid diseases •Any other clinically significant disorder •Non-obese (BMI <30) & morbidity obese (>40).
- •â€¢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.
- •â€¢History of motor weakness or peripheral sensory neuropathy •Have orthopedic joint problems that would be barrier to physical activity such as walking.
- •â€¢Are currently participating in any weight loss clinical trial.
- •â€¢Women who are pregnant and nursing mothers •People with major psychiatric illness •Any contraindication to blood sampling.
结局指标
主要结局
•Reduction in body weight and BMI
时间窗: •At Screening ,day 14,day 28 and day 56
次要结局
- •Changes in lipid profile(•Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction)