Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: Porelis 250mg/day: Oral administration of single dose of Porelis 250mg capsule every Day for 56 days
Control Intervention1: Placebo Capsules 250mg: Oral administration of single dose o
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Overweight Subject: BMI = 25.00 to 2.Subject willing to adhere with their routine diet and exercise regimen throughout the study. 3.Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening. 4. Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects suffering from intractable obesity, had defined weight limits, or had experienced any recent,unexplained weight loss or gain six months prior to screening. 2.Pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader–Willi syndrome). 3.Intake of over the counterweight loss agents, centrally acting appetite suppressants in the previous six months 4.Subjects suffering from any chronic health conditions (e.g., diabetes, hypertension, chronic renal failure, heart, thyroid, and liver disease). 5.Subjects allergic to herbal products or any component of the study product. 6. Known HIV or Hepatitis B positive or any other immuno-compromised state. 7. History of -Chronic metabolic disease -Psychiatric illness. -Drug abuse, smoking, abuse/addiction to alcohol -Bariatric surgery -Eating disorder such as bulimia or binge eating -Endocrine abnormalities including stable thyroid disease. -Cardiovascular surgery -History of any major surgery 8.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study. 9.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 |
|---|---|
| Mean Change in Body Weight & BMITimepoint: Day 0, Day 56, Day 98, Day 154 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change in Biomarker levels & Biochemical ParametersTimepoint: Day 0, Day 56, Day 98, Day 154 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed