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临床试验/CTRI/2023/03/050989
CTRI/2023/03/050989尚未招募不适用

Effectiveness of various interventions for smoked tobacco cessation among Chhattisgarh Population - a randomised control trial

Dr Milind Wasnik1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年3月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Effectiveness of various interventions used for tobacco cessation i.e. which method is more helpful in quitting tobacco habit

研究概览

简要总结

The current study is aimed to gauge the effectiveness of three different tobacco cessation interventions i.e. NRT (Nicotine Replacement therapy) alone, combination of NRT (Nicotine Replacement therapy) & counseling & combination of NRT (Nicotine Replacement therapy) and m-cessation among Chhattisgarh Population. A prospective, single-blind, randomized controlled interventional study would be carried out among patients attending the Tobacco Cessation Centre at Government Dental College, Raipur, Chhattisgarh, and a total of 150 participants who will satisfy the inclusion and exclusion criteria would be selected for the study. The selected study participants would be randomly and equally assigned to the three intervention groups (50 participants in each group) for a time span of 3 months . Participants were randomized on a 1:1:1 basis to the three groups using block randomization with variable block size of 3. Participants were randomly allocated to three different study groups composed of NRT group (Group I) (12 -week course), a combination of the both (Group II) (counseling intervention (30 min intervention with printed materials) with a 12 -week sequential course of NRT), and mCessation along with NRT (Group III). After intervention period, the abstinence from the tobacco use or decline in the frequency and quantity of tobacco use would be evaluated by a pretested questionnaire and clinical analysis of the participants by measuring the respired CO using the CO monitoring device, Nicotine Cotinine levels will be measured by Nicotine Cotinine tests in urine sample. this will help us to know that which method will be more helpful in quitting tobacco habit.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Outpatients at the hospital, within the age band of 18– 60 years
  • Participants who remained current users of “smoking form†of tobacco
  • Confirmed to remain at their current address till the completion of the study.
  • Able to provide written informed consent and understand the study protocol.
  • Access to the mobile phones.

排除标准

  • Terminal ailment (prognosis <12 months)
  • Pregnancy
  • Patients under psychiatric care
  • History of hypersensitive reactions toward nicotine or menthol
  • Previous admission into the similar study
  • Patients using both smoking and smokeless variants of tobacco.

结局指标

主要结局

Effectiveness of various interventions used for tobacco cessation i.e. which method is more helpful in quitting tobacco habit

时间窗: Effectiveness of various interventions used for tobacco cessation for Three Months.

次要结局

  • Pharmacotherapy with combination of behavioral therapy would yield in better results.(Effectiveness of various interventions used for tobacco cessation for Three Months.)

研究者

发起方
Dr Milind Wasnik
申办方类型
Other [self]

研究点 (1)

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