An Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of â??Minviteinâ?? of Essen Fooddies India Pvt. Ltd. as a Nutritional Supplement in Adult Subjects

Essen Fooddies India Pvt Ltd0 sites0 target enrollmentStarted: TBDLast updated: February 6, 2023

Trial Snapshot

No summary available.

•1.Clinically healthy adult subjects between the ages of 18 and 65 years (both ages and all genders inclusive).
•2.Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving general health.
•3.Subjects who are not on rapid weight loss programs such as but not limited to keto, paleo, warrior, caveman diets. Intermittent fasting is permitted.
•4.Subjects who have scored 12-14 in Mini Nutritional Assessment MNA-SF Questionnaire at the time of screening.
•5.Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
•6.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 diagnosed with Galactosemia.
•3.Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
•4.Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
•5.Subjects on remission from cancer of any type less than 5 years at the time of screening.
•6.Subjects who are planning a pregnancy and/or currently breastfeeding.
•7.Subjects who have participated in a clinical study less than 1 month before screening.
•8.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.
•9.Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•10.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

Sponsor

Essen Fooddies India Pvt Ltd