Efficacy and safety study of dietary supplements in chronic smokers individuals having mild to moderate hyperlipidemia
Not Applicable
- Conditions
- Health Condition 1: null- chronic smokersmild to moderate hyperlipidemia
- Registration Number
- CTRI/2014/08/004838
- Lead Sponsor
- Olive Lifesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Men >20 years.
Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC >200 mg/dL and/or HDL-C <40 mg/dL).
Being mentally competent and able to understand all study requirements and sign the informed consent form.
Exclusion Criteria
Patients with Chronic obstructive pulmonary disease (COPD).
Women.
Patients with severe liver, renal, cardiac or brain diseases.
Unable to complete follow up.
Subjects on any medication like diuretics.
Allergic to any medication.
With a history of alcohol and/or drug abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in urine cotinine and serum oxidative stress marker (malondialdehyde) levelTimepoint: Baseline, on day 30 and 60
- Secondary Outcome Measures
Name Time Method Change in serum lipid profileTimepoint: Baseline, on day 30 and 60;Safety and tolerability [physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology (CBC), biochemical tests (serum urea, serum creatinine), liver function test and urine analysis].Timepoint: Baseline, on day 30 and 60