CTRI/2017/02/007829已完成未知
A prospective open label clinical study to evaluate the efficacy and safety of Amla extract in the subjects with Abnormal lipid levels
Arjuna Natural Extracts Ltd0 个研究点目标入组 39 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
- 39
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 aged 18-65 years.
- •2.Inactive population (defined as less than 150 minutes of moderate-intensity physical activity throughout the week, or less than 75 minutes of vigorous-intensity physical activity throughout the week, or less than an equivalent combination of moderate- and vigorous-intensity activity).
- •3.Subjects with abnormal lipid levels having Triglycerides >200 mg/dL, LDL cholesterol > 130 mg/dL and Total cholesterol > 200 mg/dL.
- •4.Subjects not taking any medication (including herbal product) for management of abnormal lipid levels since last 4 weeks .
- •5.Informed consent of the patient.
排除标准
- •1.Subjects with more than 2 of the following risk factors -
- •Cigarette smoking
- •Hypertension (BP >140/90 mmHg or on antihypertensive medication)
- •Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years)
- •Age (men >45 years; women >55 years).
- •2.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 ( >160/100 mm of Hg or use of antihypertensive medications, dose of which is not stable in the last one month).
- •3.Subjects with very high triglyceride levels i.e. > 500 mg/dL.
- •4.Subjects with diabetes (FBS >150 mg/dL),, using insulin, glitazones. Subjects using other hypoglycaemics, dose of which is not stable in last one month.
- •5.Pregnancy, lactation and female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilisation).
- •6.Subjects with hepatic impairment (SGOT or SGPT levels > 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine >= 2.0 mg/dl).
- •7.Subjects with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures.
- •8.Subjects with known history of hypersensitivity to amla or any product containing amla extract .
- •9.Subjects with continuing history of alcohol and / or drug abuse.
- •10.Subjects with any other serious concurrent illness or malignancy.
- •11.Participation in another clinical trial in the past 3 months.
研究者
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