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.
试验速览
- 阶段
- 不适用
- 状态
- Other
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To determine the efficacy of XAR Capsule 500mg (containing 10.5 mg of extremely active resveratrol) on HDL, DHEA and insulin level.
研究概览
简要总结
This study is a randomized, double-blind, placebo control clinical study to determine the efficacy of XAR TM capsule (extremely active resveratrol) (bearing fssai approval number 11517001000234) 500 mg to regulate the HDL levels in 100 healthy human volunteers. The study will be conducted in India. The primary outcome measures will be HDL, DHEA and insulin levels after 30 days of treatment. The secondary outcomes will be measured on Total cholesterol, Very Low Density Lipoprotein, Low density lipoprotein, Triglyceride, Testosterone, Thrombotic, renal profile, Homocysteine, Estradiol and Anti-Mullerian Hormone. The effect of XAR will be analyzed on the expression of stem cell genes and other genes in the peripheral blood cells
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy volunteers of age 20 to 55 years of either sex who are not involved in any regular medication or supplementation.
- •Subjects having HDL level, normal, lower and less than lower range at screening visit.
- •Subjects who are willing to give their written informed consent and comply with the protocol requirements.
排除标准
- 未提供
结局指标
主要结局
To determine the efficacy of XAR Capsule 500mg (containing 10.5 mg of extremely active resveratrol) on HDL, DHEA and insulin level.
时间窗: 30 days
次要结局
- To determine the efficacy of XAR Capsule on Total cholesterol, Very Low Density Lipoprotein,(Low density lipoprotein, Triglyceride, Testosterone, Thrombotic, renal profile, Homocysteine, Estradiol and Anti-Mullerian Hormone. The effect of XAR will be analyzed on the expression of stem cell genes and other genes in the peripheral blood cells.)