Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: Salacilean: Dose :450mg,Doasge form:Capusle, Duration 84days, 1 capsule per day, after breakfast
Control Intervention1: Placebo: Dose :450mg,Doasge form:Capusle, Duration 84days, 1 caps
Sponsors
ADL Holdings
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged between 19 and 65 who are healthy and capable of normal physical activity. 2. Adults who belong to the range of BMI 25 34.9 kg per m2 and do not take drugs. 3. Adults who voluntarily decide to participate and agree in writing to abide by the precautions after hearing a detailed explanation of the clinical study and fully understand it.
Exclusion criteria
Exclusion criteria: A. Clinical Study 1. Adults who did not sign the research subject consent form 2. Adults who participated in other clinical studies within 2 months before the screening test B. Weight 3. Subjects whose body weight has changed by 5-10 percent and whose weight gain or loss is 5kg or more within 3 months. C. Disease Status 4. Subjects who have undergone obesity surgery within the last year 5. Subjects who have undergone surgery within the last 6 months 6. Subjects who are receiving or received psychotropic drug treatment and psychological treatment due to mental disorders (depression, schizophrenia) 7. Patients with cardiovascular disease, arrhythmia, heart failure, myocardial infarction, cerebrovascular disease, and those with a history of using a cardiac pacemaker 8. Patients with diabetes who are under medication or cannot be controlled 9.Gastrointestinal disease (Crohn s disease)/gastric resection/irritable bowel syndrome 10. Chronic inflammation (kidney, liver, pancreas) and infectious diseases, hypertension (systolic/diastolic 160/100mmHg or more) 11. Patients with a history of heart disease or cancer 12. Patients with thyroid disease or those taking thyroid drug substitutes 13. Patients with malabsorption syndrome/ autoimmune disease 14. Patients with liver and kidney failure 15. Subjects taking dietary supplements or drugs that may affect blood sugar and lipid metabolism, body composition, and eicosanoid production (e.g., salicylates, dairy products) 16. Patients with anaemia/ porphyria) 17. Subjects suffering from pancreatic disease, those with a history of eating disorders. D. Physiological status 18. Women who are pregnant or lactating 19. Women within 6 months of giving birth E. Medication and health functional food products 20. Subjects taking anti-obesity drugs 21. Drug addicted subjects 22. Subjects who are taking blood sugar lowering drugs, insulin, or diabetes medications 23. Subjects who are taking drugs that affect energy metabolism, blood sugar, appetite, and gastrointestinal activity 24. Subjects taking medications that affect carbohydrate and lipid metabolism, weight and hormones. 25. Subjects taking immunosuppressants, proton pump inhibitors (PPI), H2 blockers, and non steroidal anti-inflammatory drugs 26. Subjects who are taking health functional food products for reducing body fat F. Life Habit 27. Women who do not use the correct method of contraception 28. Subjects who have been on weight management for the past few years 29. Subjects who have participated in a weight loss program within the last 3 months 30. Subjects who consume excessive alcohol (exceeding 2g per day MFDS Guidelines) Ingested alcohol content (g): Intake (ml) x alcohol content (%) x 0.8 (alcohol specific gravity)/ 100. 31. Excessive smokers (more than 25 cigarettes per day) G. Allergy 32 Subjects with allergies/ side effects to the test substance excluded from the study H. Others 33. Subjects with serum creatinine 1.5mg/dL or higher 34. Subject whose AST (aspartate aminotransferase) and ALT (alanine aminotransferase) level is three times or more than the maximum normal level 35. Subject who is judged unsuitable for t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes 1. DEXA Change in body fat mass (kg), body fat percentage (%BF)Timepoint: Day 1 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. Body Weight 2.Waist circumference, Hip circumference, WHR (waist/hip ratio) 3. BMI 4. Basal metabolic rate 5. Safety Assessment (Screening Visit, Day 84)Timepoint: Day 1, Day 42, Day 84;Secondary Outcome 1. Lean mass by DEXA 2. Abdominal visceral fat & subcutaneous fat area- by CT 3. Blood Lipid 4. Secreted Hormones: Adiponectin, Leptin & InsulinTimepoint: Day 1 & Day 84 | — |
Countries
India
Contacts
Public ContactDr. Sravani T
Botanic Healthcare Pvt. Ltd
Outcome results
None listed