An Open Label, Prospective, Randomised, Intra-Comparative, Cross Over Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of â??Morning Aidâ?? of Sipwise Beverages Pvt. Ltd. in Alleviating the Symptoms associated with Alcohol Induced Hangover in Adult Subjects

Sipwise Beverages 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

暂无简介。

•1.Adults between the ages of 25 and 45 (both ages, all sexes inclusive) who are Social Drinker.
•2.Subjects must experience atleast two hangovers per month of social drinking.
•3.Subject should not have any history/diagnosis of alcoholism/alcoholic substance abuse. (Screening using SMAST)
•4.Subjects must have passed the criteria set in the Screening Questionnaire
•5.Subjects should be a non-smoker or must smoke <=10 cigarettes per day.
•6.Subjects who are willing to abstain from use of other products not limited to home remedies, soft drinks, mocktails, medications for treating hangover symptoms for the duration of the clinical study.
•7.Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
•8.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

•1.Subjects with known hypersensitivity to the ingredients of the investigational product
•2.Subjects who are on medications not limited to blood thinner that contraindication consumption of alcohol even socially.
•3.Subjects with history of liver disease not limited to AFLD, cirrhosis etc.
•4.Subjects with history of addiction to alcohol, smoking, and any other drug substance.
•5.Subjects with history or diagnosis of psychiatric disorders
•6.Subjects with history of uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
•7.Subjects with history of seizures
•8.Subjects on remission from cancer of any type less than 5 years at the time of screening
•9.Subjects who have participated in a clinical study less than 1 month before screening
•10.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
•11.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•12.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

发起方