An Open Label, Prospective, Comparative, Three Arm Study to Evaluate the Effectiveness, Safety and Tolerability of Two Doses of Anti Hangover Drink in Reducing Alcohol Induced Hangover Symptoms in Adult Male Social Drinkers.

Ms Plant Lipids Private Limited0 个研究点目标入组 36 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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 atleast 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.Subjects with full comprehension and ability to understand the purpose and the nature of trial
•5.Should be a non smoker.
•6.Should have no history of alcoholism or Alcoholic abuse (SMAST)
•7.Subjects with normal baseline laboratory parameters.
•8.Subjects who are willing to stay at the trial site during the trial period.
•9.Subjects whose blood alcohol / breath alcohol concentration is zero at the time of enrollment.
•10.Subjects with normal sleep patterns and habits.

•1.History of drug dependence or excessive alcohol intake on a habitual basis of more than two units of alcoholic beverages.
•2.Subjects with psychiatric disorders as evaluated by the modified Suicide Behaviors Questionnaire.
•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 maybe 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.

发起方

Ms Plant Lipids Private Limited