NCT03731286已完成不适用
A Double-Blind Randomized, Double-dummy, Placebo-controlled, Parallel-Group Study of the Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in ECG from baseline to end of the treatment.
研究概览
简要总结
The present study has been proposed to investigate the long-term safety and efficacy of EnXtra in healthy adults habituated to caffeine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of regular caffeine consumption.
- •Body mass index (BMI) of ≥18.5 and <25.00 kg/m
- •Fasting blood glucose < 126 mg/dl
- •Participants who are willing to complete all study procedures including study-related questionnaires and comply with study requirements.
- •Participants who are willing to abstain from use of any nutritional supplement and herbal preparation 48 hrs prior to study visit.
排除标准
- •Participants unable to abstain from caffeine-containing products for 12 hours prior to the site visit.
- •Known cases of type II Diabetes Mellitus.
- •Participants with uncontrolled hypertension (≥140/90 mm Hg), with or without anti-hypertensive medication.
- •Participants suffering from primary or secondary insomnia with/ without active treatment.
研究组 & 干预措施
Alpinia galanga
Active Comparator
EnXtra: 2 capsules to be taken twice daily after breakfast and evening.
干预措施: Alpinia Galanga (Dietary Supplement)
Composite (Alpinia galanga + Caffeine)
Active Comparator
Composite: 2 capsules to be taken twice daily after breakfast and evening.
干预措施: Alpinia Galanga (Dietary Supplement)
Placebo
Placebo Comparator
Microcellulose crystalline: 2 capsules to be taken twice daily after breakfast and evening.
干预措施: Microcellulose crystalline (Dietary Supplement)
结局指标
主要结局
Change in ECG from baseline to end of the treatment.
时间窗: 84 Days
ECG parameters including PR interval, QRS duration, QT interval and RR interval will be evaluated from baseline and end of the treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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