A Randomized, Open Label Clinical Study To Evaluate The Efficacy And Safety Of Amla Extract In Obese Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean percent change in BMI, Waist circumference, Total body fat percentage, Visceral fat percentage at the end of 90 days.
研究概览
简要总结
Obesity is one among the major health problem which is increasing day by day across the world. Obesity is defined by body mass index (BMI) and further evaluated in terms of total amount of fat and distribution of fat in the body via the waist-hip ratio. The objective of this randomized, open label, single centered clinical study is to evaluate the safety and efficacy of Amla Extracts of M/s Arjuna Natural Limited, Kerala. Sixty obese subjects with dyslipidemia will be enrolled in the study and divided into three groups. First group will be given Amla extract (AMX 160) 500 mg once daily, second group will be given Amla extract (AMX 160) 500 mg twice daily and the third group will be given Amla extract (AMX 500) 250 mg twice daily for 90 days. The effect of amla extracts on lipid levels, body composition and waist – hip ratio are assessed on Day 0, Day 45 and Day 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with BMI ≥ 35 kg/m2
- •Male subjects with waist circumference > 102 cm and female subjects with waist circumference > 88 cm.
- •Subjects with Triglycerides TG ≥ 200 mg/dL
- •Subjects who have provided signed informed consent for the trial.
排除标准
- •Subjects with uncontrolled cardiovascular disease or advanced atherosclerosis (e.g. history of stroke, myocardial infarction, life- threatening arrhythmia, or coronary revascularization within the preceding 6 months; unstable angina; congestive heart failure; known or suspected clinically significant valvular heart disease or uncontrolled hypertension or use of antihypertensive medications, dose of which is not stable in the last one month) 

- •Subjects with unstable diabetes, using insulin, glitazones, other hypoglycemic dose of which is not stable in last one month 

- •Subjects with Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years).
- •Pregnancy, lactation and female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) 

- •Subjects with hepatic impairment (SGOT or SGPT levels > 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine≥ 2.0 mg/dl) 

- •Subjects with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures 

- •Subjects with known history of hypersensitivity to amla or any product containing amla extract.
- •Subjects with history of alcohol intake daily or drug abuse.
- •Subjects with any other serious concurrent illness or malignancy.
- •Participation in another clinical trial in the past 3 months.
结局指标
主要结局
Mean percent change in BMI, Waist circumference, Total body fat percentage, Visceral fat percentage at the end of 90 days.
时间窗: Day 0, Day 45, Day 90.
次要结局
- 1. Mean percent change in TG, TC, FBS at the end of 90 days.(2. Mean percent change in Weight, Hip Circumference, Waist: Hip ratio at the end of 90 days.)
- Other outcome:(Mean change in Body Age and GPAQ –Improvement in the mean MET score at the end of 90 days.)