CTRI/2012/05/002678已完成不适用
Efficacy and safety study of herbal supplements (SR-L-01, SR-B-01 and SI-S-01) in the management of prediabetes and mild to moderate hyperlipidemia
Olive Lifesciences Pvt Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年5月4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
- 40
- 试验地点
- 1
- 主要终点
- Change in FBS,OGTT, and PPBS levels
研究概览
简要总结
This study is a randomized, double blind, parallel group, placebo controlled trial determining the safety and efficacy of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) in the management of prediabetes and mild to moderate hyperlipidemia. The primary outcome measures will be reduction in FBS, OGTT, PPBS, LDL, VLDL, HDL and TC at 6 weeks. The secondary outcomes will be Safety and tolerability at 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC >200 mg/dL and with no or one of the below risk factors •Current cigarette smoking •Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years) •Hypertension (BP ≥140/90 mmHg or on antihypertensive medication) •Low HDL-C (<40 mg/dL) •Age (men ≥ 40 years; women ≥ 40 years) 2.Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL) 3.Impaired fasting sugar (FBS levels in the range of ≥ 100 to ≤125 mg/dL) 4.Being mentally competent and able to understand all study requirements and sign the informed consent form.
排除标准
- •1.Patients with severe liver, renal, cardiac or brain diseases 2.Pregnant or lactating women or women of childbearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives) 3.Unable to complete follow up 4.Subjects on any medication that would affect evaluation like Statins 5.Allergic to any medication 6.With a history of alcohol and/or drug abuse.
结局指标
主要结局
Change in FBS,OGTT, and PPBS levels
时间窗: 3 and 6 weeks | 3 and 6 weeks
Change in LDL, VLDL, HDL and TC levels
时间窗: 3 and 6 weeks | 3 and 6 weeks
次要结局
- Safety and tolerability(6 weeks)
研究者
研究点 (1)
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