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临床试验/CTRI/2009/091/000962
CTRI/2009/091/000962已完成不适用

Study to evaluate the effect of Physicians advice in quitting smoking in HIV and TB patients in South India - A Pilot study

Tuberculosis Research Centre1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年3月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Smoking Cessation

研究概览

简要总结

Smoking is one of the major public health problems globally. Smokers who are also infected HIV develop additional risks, in addition to the general health consequences of smoking and also morbidity and mortality is higher in pulmonary tuberculosis patients with smoking.The study is a randomized clinical trial to determine the efficacy of Physician's advise strategy in quitting smoking in patients with HIV and patients with TB and to compare its efficacy rate with that of counselor counseling and administering a brochure with study materials. The primary outcome measure will be smoking cessation rate at 1 month after intervention.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • HIV group: Inclusion criteria
  • HIV positive (ELISA / Rapid test.
  • Reactive)
  • May or may not have TB.
  • Eighteen years or older
  • Willing to give informed consent
  • Current Smoker
  • Willing to undergo carbon monoxide monitor test TB group: Inclusion criteria
  • Newly detected pulmonary tuberculosis (Sputum AFB.
  • positive)
  • Eighteen years or older
  • Willing to give informed consent
  • Current Smokers
  • Willing to undergo carbon monoxide monitor test.

排除标准

  • Exclusion criteria(both HIV and TB group)
  • People who do not understand Tamil language.
  • People who have idea of relocating to another geographic area within the study period
  • Severely ill / moribund status.

结局指标

主要结局

Smoking Cessation

时间窗: 1 month after intervention

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital

研究点 (1)

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