CTRI/2019/01/017201已完成未知
A Randomized, Open Label Clinical Study To Evaluate The Efficacy And Safety Of Amla Extract In Obese Subjects.
Arjuna Natural Ltd0 个研究点目标入组 58 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects with BMI >= 35 kg/m2
- •2. Male subjects with waist circumference > 102 cm and female subjects with waist circumference > 88 cm.
- •3. Subjects with Triglycerides TG >= 200 mg/dL
- •4. Subjects with Total Cholestrol >= 200 mg/dL
- •5. Subjects who have provided signed informed consent for the trial.
排除标准
- •1. 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) â?¨
- •2. Subjects with unstable diabetes, using insulin, glitazones, other hypoglycemic dose of which is not stable in last one month â?¨
- •3. Subjects with Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years).
- •4. Pregnancy, lactation and female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) â?¨
- •5. Subjects with hepatic impairment (SGOT or SGPT levels > 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine>= 2.0 mg/dl) â?¨
- •6. Subjects with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures â?¨
- •7. Subjects with known history of hypersensitivity to amla or any product containing amla extract.
- •8. Subjects with history of alcohol intake daily or drug abuse.
- •9. Subjects with any other serious concurrent illness or malignancy. â?¨
- •10. Participation in another clinical trial in the past 3 months
研究者
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