CTRI/2016/05/006977已完成不适用
A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VEGETABLE POWDER IN THE MANAGEMENT OF CARDIOVASCULAR RISK FACTORS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ITC Limited
- 入组人数
- 288
- 试验地点
- 3
- 主要终点
- •Management of Cardiovascular risk factors (Changes in the Triglycerides)
研究概览
简要总结
A PROSPECTIVE, RANDOMIZED,DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED CLINICAL STUDY TO EVALUATE THEEFFICACY AND SAFETY OF VEGETABLEPOWDERIN THE MANAGEMENT OF CARDIOVASCULAR RISKFACTORS.
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€¢Males and females of age group 18-60 years •Patients with diabetes (FBS greater than or equal to 130 mg/dL , PPBS greater than or equal to 200 mg/dL) •Obese patients with Body mass index 25 to 35 kg/m
- •â€¢Patients prone to Cardiovascular disease (Triglycerides greater than or equal to 150 mg/dl) •Subjects must understand risks and benefits of the protocol and be able to give informed consent along with audio video visual.
- •â€¢Equal distribution of subjects receiving medication amongst the test and placebo arms.
排除标准
- •â€¢History of thyroid diseases •History of HIV positive patients •Pregnant or lactating woman •Cancer, smoking, alcohol drinking.
结局指标
主要结局
•Management of Cardiovascular risk factors (Changes in the Triglycerides)
时间窗: Screening to visit 5( Day 84)
次要结局
- Quality of life questionnaire(Changes in the FBS,PPBS)
研究者
研究点 (3)
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