Clinical Trial on Patented Polyherbal Formulation for the treatment of Obesity.
Phase 2
Completed
- Conditions
- Health Condition 1: null- Patients sufferg from Obesity and Hyperlipidemia
- Registration Number
- CTRI/2012/06/002738
- Lead Sponsor
- SJ Thakkar Pharmacy College Rajkot Gujarat
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
•BMI 27-35kg/m2
•Capable of giving written informed consent
•Subject with LDL-cholesterol >= 3.4 mmol/L and <= 6.2 mmol/L and TG <= 3.5 mmol/L.
Exclusion Criteria
•Subject has previous chronic diseases or surgical history
•Patient with any metabolic disorders
•Patients taking any medication for the obesity
•Patients with an cardiac problems
•Patients who did not signed the patient consent form
•Subject has a history of alcohol or substance abuse or dependence prior to screening
•The subject is a smoker.
•Pregnant and lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Reduction in body weight <br/ ><br>â?¢Reduction in cholesterol level <br/ ><br>Timepoint: â?¢Measurement of body weight and lipid profile after every 20 days of intervention <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢Duration of response is measured <br/ ><br>â?¢Safety will be assessed on the basis of adverse event monitoring, laboratory assessments, and incidence and causality of treatment delays/dose reductions/patient withdrawals due to toxicities. <br/ ><br>Timepoint: â?¢Efficacy and safety will be assessed on each visit each of after 20 days of intervention