A Randomized Double Blind placebo controlled parallel clinical study to evaluate the efficacy and safety of DOTSHOT in the treatment of Hangover due to alcohol intoxication
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 2. The Biochemical parameters includes:-
研究概览
简要总结
A randomized Double Blind Placebo controlled parallel clinical study to evaluate the Efficacy of Healthdrink DotShot 70 ml in the treatment of Hangover Due to alcohol Intoxication Total 30 male subject will be enrolled in the study In house study Duration of the study will not exceed 10 days To compare the safety and efficacy of Health drink DotShot 125 mg curcumin/ 70 ml and placebo in the treatment of alcohol induced Hang over
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Michigan Alcoholism Screening Test (MAST): more than 2 to
- •Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
排除标准
- •A medical history of significant hypersensitivity or allergic reaction to turmeric or related products.
- •Volunteers have history of alcohol toxicity like liver cirrhosis, neurological disease, peptic disease, diabetes, drug abuse.
- •Volunteers have undergone any concomitant medications like antibiotics, anticoagulants, tricyclic antidepressant, cardiovascular medication, sedative, hypnotics.
- •Prior to 14 days.
- •History of bile duct obstruction or Cysts of the common bile duct
- •If they have hypersensitivity for alcohol ingestion.
- •If they have habit of smoking or tobacco chewing.
结局指标
主要结局
2. The Biochemical parameters includes:-
时间窗: From Baseline To End of Treatment
a. ALDH (Acetaldehyde Dehydrogenase): Baseline, after 0, 2 hours and 10 hours of the formulation.
时间窗: From Baseline To End of Treatment
c. Blood Alcohol: Baseline, after 0, 2 hours and 10 hours of the formulation.
时间窗: From Baseline To End of Treatment
Primary Endpoints
时间窗: From Baseline To End of Treatment
1. Assessment of changes in Biochemical Evaluation from screening to end of the treatment for hangover effects.
时间窗: From Baseline To End of Treatment
b. Blood Aldehyde: Baseline, after 0, 2 hours and 10 hours of the formulation.
时间窗: From Baseline To End of Treatment
d. ALT, AST and ALP (baseline, 2 and 10 hours of formulation)
时间窗: From Baseline To End of Treatment
次要结局
- 1.Assessment of Changes in the Behaviour from screening to end of the treatment for hangover effects.(2. Behaviour study based questions:)