Efficacy and Safety Study of Dietary Supplements (BioTurmin, BioTurmin-WD and MaQxan) on Cotinine Level and Oxidative Stress Marker in Chronic Smokers Having Mild to Moderate Hyperlipidemia
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in urine cotinine and serum oxidative stress marker levels
Study Overview
Brief Summary
The purpose of this study is to investigate the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 days of intervention.
Detailed Description
In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 30 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in urine cotinine and serum oxidative stress marker levels
Time Frame: Baseline and on day 30
nicotine metabolite (cotinine) and serum oxidative stress marker (malondialdehyde) levels
Secondary Outcomes
- Change in serum lipid profile(Baseline and on day 30)