Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: Terminalia bellirica extract: Dose: 500mg
Dosage form: Capsule
Route of administration: Oral
Frequency: One capsule orally in the morning before breakfast
Duration:84 Days
Control I
Sponsors
Daehan chemtech co., Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 18 and 60 years 2. Body mass index (BMI) ranging between 25 to 32. 3. Subjects failing to control their body weight through diet therapy alone. 4. Subjects willing to follow the medication, diet, and exercise requirements as determined by the investigators. 5. Subjects with stable body weight (patient-reported body weight change less than 5 kg) in the last 3 months. 6. Capacity and willingness to provide written informed consent and adhere to the study protocols.
Exclusion criteria
Exclusion criteria: 1. Subjects who have received any medications or dietary supplements for weight reduction or management within 1 month prior to screening. 2. Subjects who have received GLP 1 receptor agonists, DPP 4 inhibitors, SGLT 2 inhibitors, or insulin therapy within 3 months prior to screening. 3. Subjects who are pregnant, intending to become pregnant during the study period, or are lactating. 4. Subjects who are participating in any rigorous exercise programs. 5. Subjects with a history of substance abuse, including drugs and alcohol. 6. Subjects with type 1 diabetes or secondary diabetes. 7. Subjects with fasting blood glucose levels greater than or equal to 126 mg/dL or who are currently on any antidiabetic medications. 8. Subjects with acute metabolic complications, such as diabetic ketoacidosis or hyperglycemic coma, within 6 months before screening 9. Subjects with obesity caused by endocrine diseases, such as Cushings syndrome. 10. Subjects with abnormal thyroid stimulating hormone (TSH) levels. 11. Subjects with thyroid nodules of unknown etiology at the time of screening, considered clinically significant by the investigator. 12. Subjects with a past or family history of medullary thyroid carcinoma (MTC) (grandparents, parents, siblings) or multiple endocrine neoplasia type 2 (MEN2). 13. Subjects with creatinine levels greater than twice the upper limit of normal. 14. Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than three times the upper limit of normal. 15. Subjects with a history of pancreatic cancer or acute or chronic pancreatitis, or with acute or chronic pancreatitis at the time of screening. 16. Subjects with acute gallbladder disease (e.g., cholecystitis, gallstones) more than twice in the 1 year before screening. 17. Subjects with severe gastrointestinal disorders affecting food intake. 18. Subjects with medical conditions known to impact serum lipid levels. 19. Subjects with uncontrolled hypertension, defined as systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg. 20. Subjects with a history of binge eating behavior, characterized by consuming a large amount of food in a short period of time with a sense of loss of control. 21. Subjects with any central nervous system disorder impeding exercise capability. 22. Subjects with major depressive disorder (MDD), anxiety disorder, or other mental illnesses at the time of screening. 23. Subjects with any musculoskeletal disorders preventing participation in exercise. 24. Subjects who have treated or plan to treat obesity with surgery or body weight loss devices during the trial. 25. Subjects with recent participation in any obesity program within the past 3 months. 26. Subjects intending to participate in another clinical study within the next month. 27. Subjects who have lost more than 5% of their body weight in the preceding 3 months. 28. Subjects with any serious systemic diseases as determined by the investigator, or other diseases believed by the investigator to potentially interfere with the results of this study or abnormal laboratory tests with clinical significance. 29. Subjects who, according to the opinion of investigators, are not suitable to participate in clinical trials, including th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the following parameters from baseline to end of treatment (Day 0 to Day 84) Total body fat mass and body fat ratio through DEXA scan (Dual Energy X-ray Absorptiometry) Timepoint: Day 0 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the following parameters from baseline to end of treatment (Day 0 to Day 84) 1. Lean body mass through DEXA scan 2. Regional fat distribution, including fat mass in the trunk region, android region, gynoid region, legs, & arms through DEXA scan 3. Resting metabolic rate through DEXA scan 4. Visceral fat area, total abdominal fat area, subcutaneous fat area, visceral-subcutaneous fat area ratio through DEXA scan 5. Laboratory parameters (serum biomarkers) a) Serum leptin b) Serum adiponectin 6. Biochemical parameters a) Serum lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, Triglycerides) Timepoint: Day 0 & Day 84;Change in the following parameters from Day 0 to Day 42 and Day 84 1. Body weight 2. BMI (Body mass index) 3. Waist circumference 4. Hip circumference 5. Waist-hip ratio 6. Thigh circumference 7. Mid-upper arm circumference Timepoint: Day 0 to Day 42 and Day 84;1. Safety (incidence of adverse events) assessment. 2. Abnormal findings in vital signs & medical interviews. 3. Abnormal changes in the hematology, urine & blood chemistry test results. Timepoint: Day 0 & Day 84 | — |
Countries
India
Contacts
Public ContactDr Vijendra R
Bangalore Clinical Services
Outcome results
None listed