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临床试验/CTRI/2026/04/109234
CTRI/2026/04/109234尚未招募不适用

Effectiveness of National Tobacco Quitline Services (NTQLS) in cessation among smokeless tobacco (SLT) users: A randomised controlled trial in Tertiary care Hospital, Odisha

Dr SATYAPRABHA ROUT1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2026年7月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
264
试验地点
1
主要终点
Point prevalence abstinence from smokeless tobacco use at 4,8,12,24 weeks

研究概览

简要总结

This study evaluates the effectiveness of National Tobacco Quitline Services (NTQLS) in helping smokeless tobacco users quit. It is a randomized controlled trial conducted among 264 participants at a tertiary care hospital in Odisha, comparing behavioural counselling alone with counselling plus quitline support. Participants will be followed for 24 weeks to assess abstinence, quit attempts, and relapse. The findings aim to determine whether NTQLS improves cessation outcomes and can serve as an effective, accessible public health strategy for tobacco control.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •1.Patients of all age groups referred to TCC of SCB Dental College and Hospital, Cuttack will be included in the study.
  • •2.Individuals who are current users of smokeless tobacco products (such as gutkha, khaini, pan masala with tobacco, snuff, or other forms).
  • •3.Individuals who are willing to quit smokeless tobacco.
  • •4.Individuals willing to participate in the cessation intervention.

排除标准

  • •1.Individuals who consume or use smoked tobacco products only (cigarettes/bidis) without smokeless tobacco use.
  • •2.Individuals who are currently enrolled in any other tobacco cessation program or clinical trial.
  • •3.Individuals receiving pharmacotherapy for tobacco cessation (nicotine replacement therapy, bupropion, varenicline, or other medications) at the time of recruitment.
  • •4.Individuals with serious medical illnesses or unstable systemic conditions that may interfere with participation or follow-up (e.g., severe cardiac disease, uncontrolled diabetes, or malignancy).
  • •5.Individuals with psychiatric disorders or cognitive impairment that limit their ability to provide reliable information or informed consent.
  • •6.Individuals who are not willing to provide informed consent or unable to comply with the study protocol and scheduled follow-up visits.
  • •7.Participants who plan to relocate or are unlikely to be available for the 24-week follow-up period.

结局指标

主要结局

Point prevalence abstinence from smokeless tobacco use at 4,8,12,24 weeks

时间窗: 4,8,12,24 weeks

次要结局

  • 1.Prolonged abstinence (continuous cessation) over a period of 24 weeks(2.Number and frequency of quit attempts)

研究者

发起方
Dr SATYAPRABHA ROUT
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr SATYAPRABHA ROUT

SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ODISHA, Odisha

研究点 (1)

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