None listed
Conditions
Interventions
Intervention1: YC-1102: 960 & 720 mg /Day Oral tablets
Twice daily at morning and night for 12 weeks. [ie., 2x (2 tablets) for 12 weeks]
Control Intervention1: Placebo: Oral Tablets
Twice daily at morning and night for 12 weeks. [i.e., 2x (2 tablets) for 12 weeks]
Sponsors
Sangol Farm
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female individuals aged from 19 to 60 (both inclusive) years 2. BMI between = 25, 3. Participants who voluntarily agrees to participate and signs on informed consent form
Exclusion criteria
Exclusion criteria: 1. Participants with a history of hypersensitivity to drugs, food ingredients, herbal extracts, or dietary supplements 2. Participants who have had participated in a commercial weight loss program or clinical trial for obesity within the last three months 3. Participants taking drugs or diet foods that affect their weight within 3 months prior to screening (absorption inhibitors, appetite suppressants, health functional foods/supplements related to obesity improvement, psychiatric drugs such as depression, diuretics, contraceptives, steroids, female hormones) 4. Participants with intentional weight loss of at least 5% within 3 months prior to screening 5. Participants who have undergone surgery, such as gastroplasty and intestinal resection, to lose weight within 6 months prior to screening 6. Endocrine diseases such as hypothyroidism and Cushing’s syndrome 7. Participants with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last 6 months (However, those who are clinically stable may participate in the trial at the investigator’ discretion) 8. Serious dysfunction of the liver (alanine and aspartate aminotransferase levels of 3.0 times the upper limit or normal) or kidney (creatinine > 2.0 mg/dL) 9. Uncontrolled hypertension (blood pressure = 160/100 mmHg) 10. Fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL, or diabetic patients taking oral hypoglycemic agents or insulin 11. Malignant tumor diagnosed within 3 years prior to screening 12. Participants who complain of severe gastrointestinal symptoms such as heartburn and indigestion 13. Participants with a psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol or the other drug abuse 14. Participants who are determined to be unable to exercise due to musculoskeletal disorders 15. Pregnant or lactating participants, or women of childbearing age who do not agree to use contraception during the trial 16. Participants with a history of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing. 17. Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator’s opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Change in body fat rate %Timepoint: Baseline and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in physical measurement ? Weight ? Waist circumference ? hip circumference ? waist circumference/hip circumference ratioTimepoint: Baseline, week 4, week 8, week 12;2) Change in Body Mass Index (BMI)Timepoint: Baseline, week 4, week 8, week 12;3) Blood lipid concentration (Total-C, HDL-C, LDL-C, Triglyceride)Timepoint: Baseline, week 4, week 8, week 12;4) DEXA (Dual-Energy X-ray Absorptiometry) ? Body fat amount(g) ? Lean body mass(g)Timepoint: Baseline, week 12;5) Abdominal fat CT (computed tomography) (between lumbar spine 4-5) ? visceral fat area, ? subcutaneous fat area, ? total abdominal fat area, ? visceral fat/subcutaneous fat area ratio (VSR) Measured.Timepoint: Baseline, week 12;6) Serum concentration measurements ? leptin ? adiponectinTimepoint: Baseline, week 12;Other Evaluations a) Dietary Record b) Physical activity (GPAQ) c) Lifestyle survey (GATS;AUDIT-C;CCQ)Timepoint: Baseline & Week 12 | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Health Pvt Ltd
Outcome results
None listed