Clinical Trial on Patented Polyherbal Formulation for the treatment of Obesity

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2012
INTERVENTION: Intervention1: SJT‐OB‐1 Capsule which contains vidang, Amla, Baheda, Harde, Piper, Ginger: two capsules to be taken thrice a day for treatment period of 75 days. Control Intervention1: Placebo: two capsules to be taken thrice a day for total treatment period of 75 days. CONDITION: Patients sufferg from Obesity and Hyperlipidemia PRIMARY OUTCOME: â?¢Reduction in body weight ; â?¢Reduction in cholesterol level ; ‐‐‐‐‐‐Timepoint: â?¢Measurement of body weight and lipid profile after every 20 days of intervention ; SECONDARY OUTCOME: â?¢Duration of response is measured ; 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. ; ‐‐‐‐‐‐Timepoint: â?¢Efficacy and safety will be assessed on each visit each of after 20 days of intervention INCLUSION CRITERIA: â?¢BMI 27‐35kg/m2 â?¢Capable of giving written informed consent â?¢Subject with LDL‐cholesterol â?¥ 3.4 mmol/L and â?¤ 6.2 mmol/L and TG â?¤ 3.5 mmol/L.
Epistemonikos ID: 36fa659728704a88cfae48e18da2d239ac04ff8a
First added on: Aug 22, 2024