CTRI/2019/05/019412已完成2 期
Randomized, placebo controlled, parallel arm, clinical study to evaluate the Effectiveness, Safety and Tolerability of Anti Hangover Drink NE-AB01 in Reducing Alcohol Induced Hangover Symptoms in Adult Male Social Drinkers.
aturedge Beverages Pvt Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adult male social drinkers between the age group of 21-35, to be
- •considered from bars, pubs and alcohol selling outlets.
- •2. Should have experienced at least one hangover previously.
- •3. Should be able to read, write comprehend the language of the ICD
- •and give his informed consent for participation in the trial.
- •4. Should have no history of alcoholism or Alcoholic abuse
- •5. Subjects whose blood alcohol concentration is zero at the time of
- •enrollment.
- •6. Subjects with normal sleep patterns and habits.
排除标准
- •1. History of drug dependence or excessive alcohol intake on a
- •habitual basis.
- •2. Subjects with psychiatric disorders.
- •3. Any history of underlying uncontrolled medical illness including
- •diabetes, liver disease or history of alcoholism, or any other serious
- •medical illness.
- •4. Subjects with history of seizures.
- •5. Subjects who may be allergic to any of the natural constituents of
- •the Investigational Product.
- •6. Subjects who are currently enrolled in an active investigational
- •study or have participated in an investigational study within 30 days
- •prior to enrollment.
- •7. Subjects, who in the opinion of the Investigator are not eligible for
- •enrollment in the study
研究者
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