CTRI/2021/03/032236尚未招募1/2 期
A double-blind randomised placebo-controlled study followed by an Open-label extension, comparative clinical study to evaluate the effect of PartySmart variants
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Change in the blood alcohol and acetaldehyde levels
研究概览
简要总结
Alcoholhangover develops when the blood alcohol concentration (BAC) returns to zeroand is characterized by a feeling of general misery that may last for more than24 hours. Several factors are known to be involved including acetaldehydeaccumulation, changes in immune system and glucose metabolism, dehydration.Hangover is suggested to be early stage of alcohol withdrawal.
The rational of study to evaluate the effect ofpolyherbal formulations PartySmart variants on alcohol hangover, in correlationwith Blood levels of alcohol and acetaldehyde in normal healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Males aged between 20-45 years, weighing more than 45 kgs 2Subject who used to drink alcohol regularly (social drink not alcohol abuse) and is willing and able to comply with the alcohol consumption requirements and overnight stay as per the study requirements 3.Subjects judged by the Investigator to be in general good health based on medical history.
- •4.Subject understands the study procedures and signs the consent forms providing informed consent to participate in the study.
排除标准
- •1.Subject suspected for drug or alcohol abuse 2.A medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation 3.Subjective sleep duration of less than 3 hours in the night before the test 4.Caffeine, nicotine or alcohol on the day (from midnight) of the test 5.Use of psycho-active drugs during the past 30 days or any treatment that might interfere with the evaluation of the test drug 6.Any drug known to interact with benzodiazepines and related drugs, e.g. antiepileptics, antihistaminics, muscle relaxant drugs, antihypertensive drugs, drugs inhibiting cytochrome P450 7.Any clinically significant disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, neurological and or psychiatric disorder etc.) 8.Known hypersensitivity to any of the ingredients of the study drugs 9.Participation in any other clinical trial within the past 30 days.
结局指标
主要结局
1.Change in the blood alcohol and acetaldehyde levels
时间窗: 12 hours
2.Clinical symptoms related to alcohol consumption
时间窗: 12 hours
3.Assessment of Alcohol Hangover Questionnaire (AHQ)
时间窗: 12 hours
次要结局
- Incidence of adverse effects.
研究者
研究点 (1)
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