A randomized, double-blind, parallel group clinical study to evaluate efficacy and safety of UO ABG 01 in the management of borderline cardio vascular risk factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- • Serum triglycerides
研究概览
简要总结
Rapidly growing prevalenceof cardiovascular disease is a major threat for the developed as well asdeveloping world warranting urgent need of intervention. Complementary andalternative medicines are gaining popularity among general population becauseof their safety profile and easy administration. Garlic, in particular, isconsidered one of the best disease-preventive foods because of its potent andwidespread effects. This study is to find out the role of garlic in the management of borderline cardio vascularrisk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects between 25 to 65 years of age Ability to understand the risks/benefits of the protocol Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy Serum triglycerides > 115mg/dL and less than < 199 mg/dL If former smoker (previously smoked ≥10 cigarettes/day for at least 1 year, cessation for at least 6 months Willing to give written informed consent and willing to comply with trial protocol.
排除标准
- 未提供
结局指标
主要结局
• Serum triglycerides
时间窗: Day -7, Day 28, Day 56 and Day 84
• Serum HDL
时间窗: Day -7, Day 28, Day 56 and Day 84
• Serum LDL
时间窗: Day -7, Day 28, Day 56 and Day 84
• Total Cholesterol
时间窗: Day -7, Day 28, Day 56 and Day 84
Change from Baseline to End of the study in
时间窗: Day -7, Day 28, Day 56 and Day 84
次要结局
- Change from Baseline to End of the study in(• Blood Pressure)