None listed
Conditions
Interventions
Intervention1: Nutricharge s & f Dose is 40 grams and the Placebo Dose is also be 40 grams.: The Total duration of the study would be 3 months. The patient will visit on Day -31, Day 0 Day 15,Day 30,
Sponsors
Ms Trophic Wellness Pvt Ltd
ClinArion Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged between 18 and 65 Years. 2. BMI >= 30 and 3. Subjects able to communicate effectively. 4. In the judgment of the Principal Investigator, able to comply with protocol requirements
Exclusion criteria
Exclusion criteria: 1. Contraindications or Hypersensitivity to study product or placebo. 2. History or presence of any medical condition or disease according to the discretion of the Investigator. 3. Clinically relevant conditions expected to preclude achievement of exercise recommendation. 4. Current use of vitamin or mineral supplements, nutritional supplements and or medical foods within 30 days prior to the beginning of the study and for the duration of the study. 5. Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss. 6. Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics) 7. Hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease. 8. Diabetes mellitus, irritable bowel syndrome, Gastro-esophageal reflux disease, HIV, hepatitis B or C, malignancy, sleep apnea, insomnia (requiring use of sleeping medication more than once weekly), night eating syndrome, Anorexia nervosa, bulimia, of non-specific eating disorder, and serious psychiatric illness 9. Female subjects who are currently pregnant and breast feeding 10. Current diagnosis or history of alcoholism or drug dependence. 11. Currently taking any medication on a regular basis. 12. Use of any experimental medication within 1 month prior to screening or as concomitant medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?? The change in the anthropometric measurements (Body Mass Index (BMI), body fat analysis and waist circumference) from baseline visit (Phase 2) to after Day 90 ± 3 (Phase 5) of treatment.Timepoint: Day 15,30,60 and 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?? Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drug. â??The change in Quality of Life from will be identified in general feedbackTimepoint: Day 0 to 90 | — |
Countries
India
Contacts
Public ContactMr Arvind Sakhi
Trophic Wellness Pvt. Ltd.
Outcome results
None listed