Health Condition 1: null- Adult male and/or female obese or overweight patients.
Conditions
Interventions
Intervention1: Curcuma caesia: One capsule twice a day for 90 days.
Intervention2: Curcuma caesia and Forskolin: One capsule twice a day for 90 days.
Control Intervention1: Placebo: One capsule twice
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and/or female patients. 2 Age between 20 to 55 years. 3 BMI between greater than 35 to 40 kg/m2. 4 Willing to come for regular follow up visits. 5 Able to give written informed consent.
Exclusion criteria
Exclusion criteria: 1 Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months. 2 Pathophysiologic or genetic syndromes associated with obesity like Cushingâ??s syndrome, Turnerâ??s syndrome, Praderwilli syndrome. 3 Patients with evidence of malignancy. 4 History of poorly controlled Diabetes Mellitus. Glycosylated haemoglobin greater than 10 percent. 5 Patients on prolonged greater than 6 weeks medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 6 Symptomatic patient with clinical evidence of Heart failure. 7 History of HIV and other viral infections. 8 Prior surgical therapy for obesity. 9 History of hypersensitivity to any of the herbal extracts or dietary supplement. 10 Pregnant or lactating woman. 11 Patients who have completed participation in any other clinical trial during the past six months. 12 Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Change in body weight and BMI. 2 Change in DEXA analysis. 3 Change in Lipid Profile. 4 Change in anthropometric measurements. 5 Clinical Photographs.Timepoint: 1 Change in body weight and BMI(Screening,Day30,Day60 and Day90). 2 Change in DEXA analysis(Day0 and Day90). 3 Change in Lipid Profile(Screening and Day90). 4 Change in anthropometric measurements(Baseline,Day30,Day60 and Day90). 5 Clinical Photographs(Screening and Day90). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Adverse Events. 2 Serious Adverse Events. 3 Abnormal Vital Signs. 4 Abnormal Laboratory Investigations.Timepoint: 1 Adverse Events(Day30,Day60,Day90 and follow up). 2 Serious Adverse Events(Day30,Day60,Day90 and follow up). 3 Abnormal Vital Signs(Screening,Day0,Day30,Day60 and Day90). 4 Abnormal Laboratory Investigations(Screening and Day90). | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
ClinWorld(P)Ltd.
Outcome results
None listed