Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: NS2129E03: Oral administration of single dose of NS2129E03 capsule everyday for 84 days
Control Intervention1: Placebo capsule: Oral administration of single dose of placebo capsule eve
Sponsors
Natural & Essential Oils Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Overweight Subject: BMI greater or equal to 25.00 to less than 30 kg/m2.2)Subject willing to adhere with their routine diet and exercise regimen throughout the study.3)Subjects not undergoing any supplementation for weight management.4)Females of childbearing age, who agree to use approved birth control methods during the study and have negative UPT at screening.5)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.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.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 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.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 Lipid Profile and Biomarkers as compared to placebo from baseline to end of the study.Timepoint: Baseline, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change in Body Composition and related parametersTimepoint: Baseline, Day 42, Day 84;Overall SafetyTimepoint: Baseline, Day 42, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt.Ltd.
Outcome results
None listed