A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GREEN SLIM IN PATIENTS WITH OBESITY, DIABETES AND HIGH CHOLESTEROL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary outcomes
研究概览
简要总结
| A Prospective, Randomized, Double blind, Placebo controlled, clinical Study to evaluate the Efficacy and Safety of GREENSLIM inpatients withObesity,Diabetes and High Cholesterol |
Primary outcomes
· Reduction in body weight and BMI, from Baseline to End of treatment
· Changes in lipid profile, blood glucose levels & HbA1C
· Changes in Waist circumference (anthropometric measurements)
· Changes in CRP, Cortisol & Liver enzymes.
· Changes in body fat percentage and lean muscle/body mass percentage
Secondary outcomes
· Safety and Tolerability assessed by Adverse Events,Subject QOL questionnaire
Drug Composition
Green Slim which contains CARALLUMA FIMBRIATA
List of excipients
The key constituents of Caralluma fimbriata are pregnaneglycosides, saponin glycosides, and bitter principles
Extract Solvents Used: Ethylalcohol
Excipients: 10% Maltodextrinmaximum
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€¢Male and female subjects aged 18 to 60 years •Obese subjects with Body mass index 25 to 35 kg/m2 •Diabetic subjects with HbA1C ≥ 7% •Moderately elevated Total serum cholesterol level •Subjects must understand risks and benefits of the protocol and be able to give informed consent along with audio video visual •Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result.
排除标准
- •â€¢Any other clinically significant disorder •Have a history of hypertension, Angina, stroke, thyroid diseases •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 •Are currently participating in any clinical trial.
结局指标
主要结局
Primary outcomes
时间窗: At Screening ,day 112
•Reduction in body weight and BMI, from Baseline to End of treatment
时间窗: At Screening ,day 112
•Changes in lipid profile, blood glucose levels & HbA1C
时间窗: At Screening ,day 112
•Changes in Waist circumference (anthropometric measurements)
时间窗: At Screening ,day 112
Secondary outcomes
时间窗: At Screening ,day 112
•Changes in CRP, Cortisol & Liver enzymes.
时间窗: At Screening ,day 112
•Changes in body fat percentage and lean muscle/body mass percentage
时间窗: At Screening ,day 112
•Safety and Tolerability assessed by Adverse Events
时间窗: At Screening ,day 112
•Subject QOL questionnaire
时间窗: At Screening ,day 112
次要结局
- Secondary outcomes(•Safety and Tolerability assessed by Adverse Events)