Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Porelis: 250 mg capsule once a day for 12 weeks
Control Intervention1: Placebo: 250 mg capsule once a day for 12 weeks
Sponsors
Vidya Herbs Pvt Ltd,
Eligibility
Inclusion criteria
Inclusion criteria: 1.Overweight subjects: BMI greater of equal to 25.00 kg per meter sqaure and lesser of equal to 30 kg per meter square 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.Subjects willing and able to give informed consent and comply with the study procedures
Exclusion criteria
Exclusion criteria: 1.Subjects having a change in body weight (gain or loss) of 5-10% or a loss of more than 5 kg within the last 3 months 2.Subjects with pathophysiologic or genetic syndromes associated with obesity 3.Intake of over the counterweight loss agents, centrally acting appetite suppressants in the previous six months 4.Subjects with a fasting blood sugar of grater or equal to 126 mg per dL, random blood sugar of greater or equal to 200 g per dL, or patients with diabetes taking oral hypoglycemic agents or insulin 5.Subjects suffering from any other chronic health conditions 6.Subjects allergic to herbal products or any component of the study product 7.Subjects with known HIV or Hepatitis B positive or any other immuno-compromised state 8.Subjects with history of Chronic metabolic disease,Psychiatric illness,Drug abuse, smoking, abuse or addiction to alcohol,Bariatric surgery,Eating disorder such as bulimia or binge eating,Endocrine abnormalities including stable thyroid disease,Cardiovascular surgery and History of any major surgery 9.Subjects currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 10.Subjects currently participating or having participated in obesity clinical trial during the last 6 months prior to the beginning of this study 11.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 the body weight, BMI and body fat compositionTimepoint: Baseline, Day 28, Day 56 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in biomarkersTimepoint: Baseline, Day 28 and Day 84;Mean change in lipid profileTimepoint: Baseline, Day 28 and Day 84;Mean change in anthropometric parametersTimepoint: Baseline, Day 28, Day 56 and Day 84;Safety AssessmentTimepoint: Baseline, Day 28, Day 56 and Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed