Health Condition 1: E663- Overweight
Conditions
Interventions
None listed
Sponsors
Herbalyn Lifesciences Inc
In Vitro Research Solutions iVRS Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a. Adult males and non-pregnant females aged 18 to 60 years. b. Have a BMI of 25.0 kg/m2and above, along with body fat of >25%. c. Stable body weight during the previous 3 months (less than 5 kg self-reported weight change) d. Not one of the following eating disorders by subjects declaration anorexia nervosa, bulimia nervosa. e. Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG), and laboratory evaluation with a special emphasis on metabolic parameters (fasting glucose concentration f. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study. g. Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.
Exclusion criteria
Exclusion criteria: a. Diagnosis of type 1 or type 2 diabetes b. Visit 1 thyroid-stimulating hormone (TSH) outside of the range of 0.4- 4.5 �¼IU/mL c. History of chronic pancreatitis or idiopathic acute pancreatitis and other chronic gastroenterological disease d. Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome) e. Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial f. Current participation in an organized diet reduction program (or within the last 3 months) g. Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial) h. Subjects on prescription and non-prescription appetite or weight modifying drugs including herbal products i. Used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline to end of the treatment (Day 90) (along with the percentage of participants who achieve a minimum of 10% weight lossTimepoint: day 0 to day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Change in Body Fat, Waist Circumference and Body Mass Index (BMI) From Baseline to end of the treatment (Day 90) ââ?¬Â¢ Change in lipid profile From Baseline to end of the treatment (Day 90) ââ?¬Â¢ Change from Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL) and Weight-Related Symptom Measure (WRSM). ââ?¬Â¢ Treatment-emergent adverse events (including laboratory abnormality)Timepoint: day 0 to day 90 | — |
Countries
India
Contacts
Public ContactT Vijay Bhaskar
In Vitro Research Solutions Pvt. Ltd.
Outcome results
None listed