A randomized, double blind, parallel assignment, placebo-controlled, two arm study to evaluate the safety and efficacy of iPulse (multi fruit blend juice) in overweight adult healthy volunteers

IndusViva HealthSciences Pvt Ltd0 个研究点目标入组 80 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1)Age/sex: men and women (1:1, equal distribution) aged 18-55 years (Preferably subgroup of age 18-35 and age 36-55, if feasible)
•2)Subject with BMI 25-30 kg/m2
•3)Subjects who perceive themselves to be under stress and having a score of 14-24 on the Perceived Stress Scale (PSS).
•4)Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the investigator
•5)Subject willing to provide written informed consent and comes for regular follow up.
•6)Subjects who agree to stop from using supplements during the study
•7)Subjects willing to follow the suggested diet plan

•1)Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
•2)Known history of any chronic illness taking regular pharmacological agents.
•3)Significant Gastrointestinal (i.e. inflammatory bowel disease, celiac), liver or kidney disease
•4)Cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure)
•5)History of major cardiovascular events in the last 1 year (stroke or myocardial infraction)
•6)History of drug dependence or any severe co-morbid medical conditions.
•7)High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc., Nicotine/Caffeine dependence.
•8)Administration of any other multivitamins/herbal product/wellness products
•9)Subject has participated in a clinical study within the last 30 days prior to entering this study.

发起方

IndusViva HealthSciences Pvt Ltd