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临床试验/CTRI/2021/10/037366
CTRI/2021/10/037366尚未招募4 期

EFFECTIVENESS OF NICOTINE REPLACEMENT THERAPY AND BEHAVIOURAL INTERVENTION IN TOBACCO CESSATION - A TERTIARY HOSPITAL BASED RANDOMISED CONTROLLED TRIAL

Cipla Pharmaceutical Company1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年10月18日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
tobacco abstinence rate

研究概览

简要总结

Tobacco use is a leading cause of preventabledeaths all over the world and worldwidethere are nearly1.2 billion users of nicotine and tobacco products causing morethan 5million deaths per year. Across studies, it has been found that themorbidity and mortality associated with tobacco use are substantially reducedby its complete cessation. The rationale of nicotine replacing therapy for nicotinedependence treatment is based on theory of harm reduction by making it easier toreplace the nicotine obtained from tobacco thereby providing nicotine mediatedneuropharmacological effect. As per Global AdultTobacco Survey India (GATS 2, 2016-17) 42.4% of men, 14.2% ofwomen and 28.6% (266.8 million) of all adults use tobacco (smoked and/orsmokeless tobacco), while in Odisha 45.6% of adults ( >15 years) are tobaccousers from which  2.8% are smoked, 38.6%are smokeless and 4.3% are both smoked and smokeless tobacco users. Despite of such prevalence of tobacco use inIndia, very few studies have been done for tobacco cessation using Nicotinereplacement therapy as an intervention and not a single such study has yet beendone in Odisha.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Individuals more than 18years of age using smoke or smokeless form of tobacco with high or moderate dependency based on modified Fagerstrom scoring criteria and residing within 100Km from the institution.

排除标准

  • Tobacco users with unstable angina, severe cardiac arrhythmia, recent acute myocardial infarction or cerebrovascular accident in preceding 3 months, pregnant and breast feeding women and tobacco users with a previous history of failure to NRT will be excluded from the study.

结局指标

主要结局

tobacco abstinence rate

时间窗: 6 months and 12 months

次要结局

  • comparing effect of different therapies on cessation of smoking and smokeless tobacco.(6 months and 12 months)
  • the oral health status(baseline, 3 months, 6 months & 12 months)
  • tobacco dependency(baseline, 3 months, 6 months and 12 months)

研究者

发起方
Cipla Pharmaceutical Company
申办方类型
Pharmaceutical industry-Global

研究点 (1)

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