Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: Afperfit: 250mg capsules twice a day for 84 days
Control Intervention1: Placebo: 250mg capsules twice a day for 84 days
Sponsors
Vidya Herbs Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and Female Subjects 2 Overweight Subject: BMI >= 25.0 to 3 Subject willing to adhere with their routine diet and exercise regimen throughout the study. 4 Must be willing and able to give informed consent and comply with the study procedures
Exclusion criteria
Exclusion criteria: 1 Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart and liver disease) 2 Subjects with fasting blood sugar above the normal limits during screening 3 History of Chronic metabolic disease Psychiatric illness Drug abuse, smoking, abuse/addiction to alcohol Eating disorder such as bulimia or binge eating Endocrine abnormalities including stable thyroid disease History of any major surgery, including cardiovascular surgery and bariatric surgery 4 History of allergic reaction to contrast dye, herbal products or any component of the study product 5 Subjects on other therapies such as Homeopathy / Ayurveda 6 Subjects with positive HIV card test during screening 7 Known Hepatitis B positive or any other immuno-compromised state 8 Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation 9 Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 10 Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in whole body energy expenditure from baseline to end of the study 2.Change in body composition and fat distribution from baseline to end of the study Timepoint: Day 0, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in BMI from baseline to end of the studyTimepoint: Day 0, Day 42. Day 84;Changes in body weight from baseline to end of the studyTimepoint: Day o, Day 42, Day 84;Changes in Questionnaire based assessmentsTimepoint: Day 0, Day 42, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Private Limited
Outcome results
None listed