A randomized double blind placebo controlled parallel clinical study to evaluate the efficacy and safety of PARTY ZESTAHO liquid Curcumin for the prevention 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
- 60
- 试验地点
- 1
- 主要终点
- Assessment of changes in Biochemical Evaluation of the prevention for hangover effects for both the groups
研究概览
简要总结
A randomized double blind placebo controlled parallel clinical study to evaluate the efficacy and safety of PARTY ZEST AHO-liquid (Curcumin)for the prevention of hangover due to alcohol intoxication.
Total Sixty(60) Healthy male subjects was enrolled in the study
In house study
Duration of study was not exceed 10 days.
To Compare the safety and efficacy of Health drink PARTY ZESTAHO-liquid 275 mg of herbal actives per drink and PLACEBO for the prevention of alcohol induced hangover.
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
- •1 Healthy male 2 Age 25-45 years have the willingness to undergo alcohol drinking 3 Michigan Alcoholism Screening Test more than 2 to 5 (Attachment no.1) 4 Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
排除标准
- •1 A medical history of significant hypersensitivity or allergic reaction to turmeric or related products 2 Volunteers have history of alcohol toxicity like liver cirrhosis neurological disease peptic disease diabetes drug abuse 3 Volunteers have undergone any concomitant medications like antibiotics, anticoagulants, tricyclic antidepressant, cardiovascular medication, sedative, hypnotics.
- •Prior to 14 days 4 History of bile duct obstruction or Cysts of the common bile duct 5 If they have hypersensitivity for alcohol ingestion 6 If they have habit of smoking or tobacco chewing.
结局指标
主要结局
Assessment of changes in Biochemical Evaluation of the prevention for hangover effects for both the groups
时间窗: From baseline to end of treatment
The Biochemical parameters includes
时间窗: From baseline to end of treatment
2.Blood Aldehyde Baseline, after 0, 2 hours and 10 hours of the formulation
时间窗: From baseline to end of treatment
3.Blood Alcohol Baseline, after 0, 2 hours and 10 hours of the formulation.
时间窗: From baseline to end of treatment
1.ALDH (Acetaldehyde Dehydrogenase) Baseline after 0, 2 hours and 10 hours of the formulation
时间窗: From baseline to end of treatment
4.ALT, AST and ALP (baseline, 2 and 10 hours of formulation)
时间窗: From baseline to end of treatment
次要结局
- Assessment of Changes in the Behaviour of the prevention for hangover effects for both the groups(Behaviour study based questions)