Health Condition 1: null- Adult male or female patients with BMI greater than equal to 35 to 40 kg/m2
Conditions
Interventions
Intervention1: Curcuma caesia: One capsule twice a day for 90 days.
Control Intervention1: Placebo: One capsule twice a day for 90 days.
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and/or female patients. 2 Age between 20 to 60 years. 3 BMI between > 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/ genetic syndromes associated with obesity (Cushingâ??s syndrome, Turnerâ??s syndrome, Praderwilli syndrome). 3 Patients with evidence of malignancy. 4 Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergic, etc. or any other drugs that may have an influence on the outcome of the study. 5 Symptomatic patient with clinical evidence of Heart failure. 6 History of HIV and other viral infections. 7 Prior surgical therapy for obesity 8 History of hypersensitivity to any of the herbal extracts or dietary supplement. 9 Pregnant / lactating woman. 10 Patients who have completed participation in any other clinical trial during the past six (06) months. 11 Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Body weight and BMI. 2 Biomarkers. 3 Lipid Profile. 4 Anthropometric measurements. 5 Clinical Photographs. 6 QOL Questionnaire.Timepoint: 1 Body weight and BMI(Screening,Visit3,Visit4 & Visit5). 2 Biomarkers(Baseline & Final visit). 3 Lipid Profile(Screening & Final visit). 4 Anthropometric measurements(Baseline,Day30,Day60 & Day90). 5 Clinical Photographs(Screening & Final visit). 6 QOL Questionnaire (Baseline & Final visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Adverse or serious adverse events. 2 Abnormal vital signs. 3 Abnormal lab investigations.Timepoint: 1 Adverse or serious adverse events(Day30,Day60 & Day90). 2 Abnormal vital signs(Screening,Day0,Day30,Day60 & Day90). 3 Abnormal lab investigations(Screening & Day90). | — |
Countries
India
Contacts
Public ContactMr Sanjib Panda
ClinWorld(P)Limited
Outcome results
None listed