CTRI/2015/10/006277已完成不适用
A single centre, open label study to assess the safety and efficacy of oral herbal capsule to improve HDL, DHEA and insulin level in healthy volunteers.
Spectrum Clinical Research Pvt Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年10月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the effect of treatment on HDL, DHEA and insulin level
研究概览
简要总结
Purpose of this study is to determine effect of capsule containing herbal extract in healthy volunteers. This is A single centre, open label study to assess the safety and efficacy of oral herbal capsule to improve HDL, DHEA and insulin level in healthy volunteers. The study includes only one group. Subject in group will consume capsule containing herbal extract thrice a day for 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy volunteers of age 20 to 55 years of either sex who are not involved in any regular medication or supplementation.
- •2.Subjects having HDL level normal, lower and less than lower range at screening visit.
- •3.Subjects who are willing to give their written informed consent and comply with the protocol requirements.
排除标准
- •1.Pregnant or lactating women.
- •2.Subjects with known hypersensitivity to the investigational products.
- •3.Subjects who have participated in any clinical trial in the past 1 month.
- •4.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.
- •5.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
结局指标
主要结局
To evaluate the effect of treatment on HDL, DHEA and insulin level
时间窗: 15 and 30 Days from Baseline Visit
次要结局
- To evaluate the effect of treatment on following parameters such as TC, VLDL, LDL, TG, TC/HDL ratio, LDL/HDL ratio, Testosterone, Thrombotic (PT and PTT), renal profile, Homocysteine, Estradiol and AMH(30 Days from Baseline Visit)
研究者
研究点 (1)
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