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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- change in urine cotinine and serum oxidative stress marker (malondialdehyde) level
研究概览
简要总结
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 and 60 days of intervention.
详细描述
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 60 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
change in urine cotinine and serum oxidative stress marker (malondialdehyde) level
时间窗: Baseline, on day 30 and on day 60
次要结局
- Change in serum lipid profile(Baseline, on day 30 and on day 60)