To study the differences in the effects of various drugs in patients suffering from metabolic syndrome, which is a cluster of conditions such as obesity, increased blood pressure and disordered cholesterol levels that increases the risk of heart diseases, diabetes and stroke.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Metabolic Syndrome
- Registration Number
- CTRI/2014/10/005139
- Lead Sponsor
- Department of Pharmacology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
Patients with 18-60 years of age and either sex diagnosed with Metabolic Syndrome. Conformation to written informed consent.
Exclusion Criteria
Patient not willing to give informed consent, type I diabetes mellitus, type II diabetes mellitus(fasting plasma glucose of >126mg/dl), severely deranged lipid profile(TG >500 mg/dl, LDLC >250mg /dl), liver enzymes >2 times of upper limit and serum creatinine >2mg/dl, history of heart disease, familial dyslipidemia, hyper or
hypothyroidism, major medical/surgical illness, hypersensitivity to any of the used drugs, pregnant and lactating females, patient on any other long term concomitant drugs known to affect
glucose tolerance or lipid profile
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum triglycerideTimepoint: Baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method Fasting plasma glucoseTimepoint: Baseline and 12 weeks;hsCRPTimepoint: Baseline and 12 weeks;Serum adiponectinTimepoint: Baseline and 12 weeks;Serum high density lipoproteinTimepoint: Baseline and 12 weeks;Waist circumferenceTimepoint: Baseline and 12 weeks