A Prospective, Randomized, Double blind, Parallel group, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of CGA-7 on the Risk Factors of Obesity
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1.Reduction in body weight and BMI at week 4, 8 and 12 of treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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
- •Patients who are willing to give written informed consent.
- •Patient is willing and able to comply with all trial requirements
- •Overweight or obese; BMI between 25-30.
排除标准
- •â€¢ Subjects with BMI >30 • Cigarette smoker, History of heart, liver and kidney disease, hypertension, pregnancy, lactating, Type 1 diabetes and weight loss medication.
结局指标
主要结局
1.Reduction in body weight and BMI at week 4, 8 and 12 of treatment
时间窗: 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 (%)
时间窗: 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)
次要结局
- 1.Changes in lipid profile (Triglycerides, cholesterol, HDL and LDL)(2.Blood pressure)