A double blind, randomized, placebo controlled study to determine the safety and efficacy of supplementation of UB0316 in weight management.

nique Biotech Ltd0 个研究点目标入组 90 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Both males & females between 30-65 years of age
•2.BMI between 23 kg/ m2 and 32-kg/ m2.
•3.Female, not currently pregnant or breast feeding and are using mechanical contraceptive devices such as Intra-uterine devices (IUD). (Barrier method of birth control; abstinence) prior to entry into study, during the period of study participation.
•4.Ability to understand and the willingness to sign and date a written Informed Consent document at the screening visit before any protocol specific procedures are performed.

•1.Subjects known to be suffering from obesity caused by a medical condition i.e. secondary cause of obesity, diabetes mellitus, and/ or uncontrolled hypertension and hypothyroidism.
•2.Subject has an HbA1c level > 9.0% at Screening/Baseline.
•3.Subject has fasting blood triglycerides > 400 mg/dL and/or LDL cholesterol > 190 mg/dL at Screening/Baseline.
•4.Patients who had been using any commercial preparation of probiotics, herbal or alternative medicine in last 3 months.
•5.History of other systemic severe diseases.
•6.Subjects with history of depression, eating disorders such as anorexia nervosa, bulimia nervosa.
•7.Pregnant or lactating females; females with history of PCOS will not be included in the study.
•8.Known hypersensitivity to any of the study drugs or constituents

发起方

nique Biotech Ltd