None listed
Conditions
Interventions
Intervention1: UB-0316: Two capsules of UB 0316 is to be taken orally per day for a period of 12 weeks.
Control Intervention1: Placebo: Two capsules of Placebo has to be taken orally per day for 12 we
Sponsors
Unique Biotech Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction of BMI (Baseline week 4, week 8 and week 12)Timepoint: 1.Reduction of BMI (Baseline week 4, week 8 and week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Anthropometric assessment,BMI,WHR. (Baseline, Week 4,8 and 12) 2.Body fat composition by bioelectrical impedance; specific to total body fat% and visceral fat% (Baseline, Week 4,8 and 12) 3.Change in lipid profiles are measured by TG, LDL, VLDL, HDL and TC. (Baseline and Week 12) 4.Changes in the blood glucose levels. (Baseline and Week 12) 5.Quality of Life Assessment (Baseline and Week 12) 6.Patientsâ?? Global Assessment scale (Week 12)Timepoint: 1.Anthropometric assessment,BMI,WHR. (Baseline, Week 4,8 and 12) 2.Body fat composition by bioelectrical impedance; specific to total body fat% and visceral fat% (Baseline, Week 4,8 and 12) 3.Change in lipid profiles are measured by TG, LDL, VLDL, HDL and TC. (Baseline and Week 12) 4.Changes in the blood glucose levels. (Baseline and Week 12) 5.Quality of Life Assessment (Baseline and Week 12) 6.Patientsâ?? Global Assessment scale (Week 12) | — |
Countries
India
Contacts
Public ContactDr Jayanthi Neelamraju
Clinical Research Department
Outcome results
None listed