Efficacy and safety study of dietary supplements in chronic smokers individuals having mild to moderate hyperlipidemia

Not yet recruiting

• Conditions: chronic smokers; mild to moderate hyperlipidemia

• Registration Number: CTRI/2014/08/004838
• Lead Sponsor: Olive Lifesciences Pvt Ltd

Brief Summary

This study is a randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of dietary supplements on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia. The primary outcome measure will be change from baseline in urine cotinine level and serum oxidative stress marker level after 30 and 60 days of treatment. The secondary outcome measure will be safety and tolerability.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2014-05-08
• Study Start: 2014-08-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• 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).
• 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) level	Baseline, on day 30 and 60

Secondary Outcome Measures

Name	Time	Method
Change in serum lipid profile	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].	Baseline, on day 30 and 60

Trial Locations

Locations (1)

Sreenivasa clinic and diabetic care centre; 🇮🇳 Bangalore, KARNATAKA, India

Sreenivasa clinic and diabetic care centre

🇮🇳Bangalore, KARNATAKA, India

Dr Venkateshwarlu K

Principal investigator

9945232107

drvenkatesh64@gmail.com