Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: Caralluma fimbriata: Dose :450mg,Doasge form:Capusle,
Duration 84days, 1 capsule per day, after meal
Control Intervention1: Placebo: Dose :450mg,Doasge form:Capusle, Duration 84days, 1
Sponsors
Three H Labs Co LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female individuals aged from 19 to 60 both inclusive 2 BMI between greater than or equal to 25 and less than 32 kg per m2 3 Those 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 foodssupplements related to obesity improvement psychiatric drugs such as depression diuretics contraceptives steroids female hormones 4 Participants with intentional weight loss of at least 5 percentage 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 Cushings 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 more than 2.0 mg per dL 9 Uncontrolled hypertension blood pressure More or equal than 160 per 100 mmHg 10 Fasting blood glucose more or equal than 126 mg per dL or random blood glucose more or equal than 200 mg per dL or diabetic patients taking oral hypoglycaemic 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 have irregular dietary habit and intakes excessive alcohol caffeine and smoke 15 Participants who are determined to be unable to exercise due to musculoskeletal disorders 16 Pregnant or lactating participants or women of childbearing age who do not agree to use contraception during the trial 17 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 18 Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigators opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: â?¢DEXA (Dual Energy X-ray Absorptiometry) Body Fat Mass Body Fat Rate. Timepoint: Day 1 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes: â?¢Body Weight â?¢Body Mass Index â?¢ Safety Assessment ( Screening Visit, Day 84) â?¢Waist circumference, â?¢Hip circumference â?¢Waist-hip ratio â?¢Skinfold of Biceps & Triceps of Arm (Day 1 & Day 84)Timepoint: screening visit, Day 1, Day 42 & Day 84;Secondary outcomes: â?¢DEXA â?¢ Lean Mass â?¢ Body Fat Mass of Individual Parts (Arm, Legs, Trunk, Android, Gynoid) â?¢ Muscle Mass â?¢ Appendicular Skeletal Muscle Mass â?¢ CT 1.Visceral fat volume 2.Subcutaneous fat volume 3.Total abdominal fat volume 4.Visceral/subcutaneous fat volume ratio â?¢Blood Lipid parameters Total cholesterol HDL-cholesterol LDL-cholesterol Triglyceride â?¢Leptin â?¢Adiponectin â?¢GLP-1 â?¢Ghrelin â?¢PYY (Peptide YY) â?¢Fasting blood glucose â?¢Fasting insulin â?¢HOMA-IRTimepoint: Day 1 & Day 84 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Private Limited
Outcome results
None listed