A study to evaluate, safety and efficacy of probiotic UB 0316 as an adjuvant in adults suffering from obesity in comparison with placebo.
- Registration Number
- CTRI/2017/05/008678
- Lead Sponsor
- nique Biotech Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method