se of Nicotine to stop tobacco addiction in tuberculosis patients
Phase 3
Completed
- Conditions
- Health Condition 1: A150- Tuberculosis of lung
- Registration Number
- CTRI/2022/06/043045
- Lead Sponsor
- PRAVARA INSTITUTE OF MEDICAL SCIENCES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Active tuberculosis (Pulmonary or Extra pulmonary) patient who are on Directly Observed Treatment & Short Course Chemotherapy and not have completed more than one month of therapy
2. Patient of either gender >= 18 years of age
3. Habituated/Addicted to Tobacco (Smoking/Smokeless)
4. Ready to give informed consent
Exclusion Criteria
Sever debilitating patients
2. HIV associate Tuberculosis
3. MDR/XDR patients
4. Not willing to 06 (01 per week) follows up
5. Participants who quit smoking within 04 weeks of trial
6. Patients contraindicated for NRT (recent history of myocardial infarction, angina; pregnancy & lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method smoking abstinence or non-abstinenceTimepoint: weekly follow up for 6 weeks
- Secondary Outcome Measures
Name Time Method number of quit attempts, number of times tobacco consumed, number of smoked cigarettes/bidis per day, smoking excess or smoking reduction, continued use and relapse from the baseline information.Timepoint: weekly follow up for 6 weeks