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

Essen Fooddies India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年2月6日

试验速览

暂无简介。

•1.Adult subjects between the ages of 21 and 65 years (both ages and all genders inclusive) with active joint pain.
•2.Subjects who are willing to abstain from the use of herbal, allopathic or other nutritional supplements that are indicated at improving joint pain, joint and muscle health.
•3.Subjects who have a pain score of 2-5 on a 10 point VAS at the time of screening in a minimum of one joint.
•4.Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
•5.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 collagen supplements in any form.
•3.Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product.
•4.Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
•5.Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
•6.Subjects on remission from cancer of any type less than 5 years at the time of screening
•7.Subjects who are planning a pregnancy and/or currently breastfeeding.
•8.Subjects who have participated in a clinical study less than 1 month before screening.
•9.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.
•10.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•11.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

发起方

Essen Fooddies India Pvt Ltd