A Double-Blind, Randomized, Crossover, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of PartySmart Soft Chews

Himalaya Wellness Company1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2025年2月6日最近更新: 2025年5月22日

适应症

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方: Himalaya Wellness Company
入组人数: 50
试验地点: 1
主要终点: Primary efficacy outcome: •Blood alcohol and acetaldehyde levels

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Alcohol hangover develops when the blood alcohol concentration(BAC) returns to zero and is characterized by a feeling of general misery that may last for more than 24 hours. Several factors are known to be involved including acetaldehyde accumulation, 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 of polyherbal formulation Partysmart soft chews on alcohol hangover, in correlation with Blood levels of alcohol and acetaldehyde in normal healthy Volunteer.

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: 20.00 Day(s) 至 50.00 Day(s)（—）
性别: All

入选标准

•1.Male and female participants aged between 20 to 50 years, with BMI 18.5 to 25 kg per m
•2.Participants with previous history of social alcohol consumption and hangover symptom score (HSS) greater than
•3.Participants who used to drink alcohol regularly or more than once in a month(social drinking, but not alcohol abuse) and are willing and able to comply with the alcohol consumption, blood withdrawal requirements and overnight stay as per the study requirements.
•4.Participants judged by the Investigator to be in general good health based on medical history and laboratory investigations.
•5.Participants understand the study procedures and sign informed consent forms to participate in the study.
•6.Women of child bearing potential and men with partners of child bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
•Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria a.
•Has not undergone a hysterectomy or bilateral oophorectomy or b.
•Has not attained menopause (Women not menstruating for at least 12 consecutive months).
•Male participants who are willing to refrain from donating sperm from first admission to the study until 90 days after the study completion.

排除标准

•1.Excessive drinking or alcohol intake in the past one week.
•2.Participants who have participated in a any other clinical trial within last 1 month.
•3.Known history of alcohol abuse or dependency or drug abuse that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions or study procedures.
•Any other conditions (physical, psychological, social or uncontrolled dietary measures) that can interfere with the participant’s compliance to the study in the opinion of the Investigator.
•Participantive sleep duration of less than 3 hours in the night before every study period.
•Participants taking any dietary supplements or medications within last 1month that may affect alcohol metabolism as per Investigator’s discreation.
•Participants with known clinically significant disorders like Alcohol metabolism disorders, diabetes, hypertension, cholelithiasis, pancreatitis, gout, active tuberculosis, Gastrointestinal bleeding, kidney or liver disease (hepatitis B or C carriers, alcoholic Liver disease, etc.), heart, lung, gastrointestinal, nervous system disease or any other chronic disorder that can interfere with the study conduct in the opinion of the Investigator.
•Participants with known history or present condition of allergic response to any of the ingredients in the investigational product.
•Pregnant as assessed by UPT and History of Amenorrhea and lactating women.