A non-randomized, uncontrolled, open label single arm trial toevaluate the safety of a poly-herbal formulation, iVed in healthyhuman subjects

IndusViva HealthSciences Pvt Ltd0 个研究点目标入组 40 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.Men and women aged 18-55 years
•2.Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the investigator
•3.Subject willing to provide written informed consent and comes for regular follow up

•1.A know history or present condition of allergic response to any pharmaceutical products and supplements.
•2.History of major cardiovascular events in the last 1 year (stroke or myocardial infraction).
•3.Gastrointestinal(i.e. inflammatory bowel disease, celiac), liver(ASL/ALT above two times the upper limit of normal) or kidney disease (eGFR < 60 ml/min/1.73 k/m2).
•4.Cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure).
•5.Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
•6.Post-menopausal female subjects.
•7.History of drug dependence or any severe co-morbid medical conditions.
•8.High alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine/Caffeine dependence or chronic smoker.
•9.Administration of any other multivitamins/herbal product/wellness products
•10. Subject has participated in a clinical study within the last 30 days prior to entering this study

发起方

IndusViva HealthSciences Pvt Ltd