Health Condition 1: null- Obesity
Conditions
Interventions
Intervention1: caralluma fimbriata extract 500 mg: Caralluma Fimbriata Extract is an anti-obesity nutraceutical containing standardized extract of the cactus Caralluma fimbriata 500mg. Standardized e
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient willing to sign Inform Consent Form (ICF) 2. Female patient not planning to conceive for 6 months during study period ( willing to use contraception during study period ) 3. Either sex patient between 18 and 55 years of age 4. Body mass index >= 25-40 kg/m2 5. Already on tablet Caralluma Fimbriata extract 500 mg since last 1-30 days 6. Could understand the options offered and the study process 7. Patients who are willing to comply with the requirements of study 8. Patient willing for follow up for at least 6 months
Exclusion criteria
Exclusion criteria: 1. Patients with pregnancy and/or lactation 2. Patient with Hypertension 3. Patient with diabetes mellitus (either type 1 or type 2) 4. Patients going to plan pregnancy and/or lactation in next one year 5. Patient with certain diseases within the previous year; a history of depression, schizophrenia, anticoagulation problems, trauma, or surgery within 3 months of study commencement 6. Participation in another clinical trial within 1 month of the study 7. Patient undergoing or who recently underwent coronary artery bypass graft (CABG) surgery 8. Patient with history of myocardial infarction or stroke in last 2 year 9. Candidates with a history of bariatric surgery or medical problems that contraindicated treatment in either study group 10. Patient who has impaired mental status, drug or alcohol addiction, or portal hypertension 11. Patient who have demonstrated allergic-type reactions Caralluma fimbriata extract 12. Patient with significant hepatic or renal insufficiency 13. As deemed inappropriate for enrollment by investigating physician due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Proportion of patients having 5% or more weight reduction from baseline and maintaining the same throughout the study period [ Time Frame: 0, 1, 3, and 6 months post baseline ] â?¢ Appetite suppression assessed on VAS scale using hunger as variable from baseline [ Time Frame: 0, 1, 3, and 6 months post baseline ] Timepoint: [ Time Frame: 0, 1, 3, and 6 months post baseline ] | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Reduction of body mass index (BMI) in Percentage and reduction in waist circumference in Percentage [Time Frame: 1, 3, and 6 months post baseline ] â?¢ Improvement in body composition analysis (BCA) reduction in percentage of body fat [Time Frame: 1, 3, and 6 months post baseline ] â?¢ Improvement in skeletal muscle percentage [ Time Frame: 0, 1, 3, and 6 months post baseline ] Timepoint: [ Time Frame: 0, 1, 3, and 6 months post baseline ] | — |
Countries
India
Contacts
Public ContactDr Hemant Zaveri
Gujarat Endocrine centre
Outcome results
None listed