CTRI/2014/08/004838尚未招募不适用
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
Olive Lifesciences Pvt Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年8月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in urine cotinine and serum oxidative stress marker (malondialdehyde) level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
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 60
次要结局
- 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)
研究者
研究点 (1)
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