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Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 09:51:50 GMT)

CTRI Number CTRI/2018/11/016457 [Registered on: 28/11/2018] - Trial Registered Prospectively Last Modified On 12/11/2018 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Behavioral Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study Smoking quit rates among pulmonary tuberculosis patients undergoing brief advice with or without nicotine replacement therapy Scientific Title of Effectiveness of Smoking Cessation among Pulmonary Tuberculosis Patients Undergoing Directly Study Observed Therapy Short Course- A Randomized Controlled Trial Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Sanjeev Badiger Trial Coordinator (multi-center study) Designation Professor Affiliation Nitte University, Mangaluru, Address Department of Community Medicine, K S Hegde Medical Academy, Deralakatte, Mangaluru Medical Sciences Complex, 6th Floor, Nitte University, Deralakatte, Mangaluru Dakshina 575018 India Phone 9242753747 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Jagannath Purushothama Query) Designation Assistant Professor Affiliation Nitte University, Mangaluru, India Address Department of Public Health, K S Hegde Medical Academy, Deralakatte, Mangaluru University Sciences Complex, Nitte University, Deralakatte, Mangaluru 575018 KARNATAKA 575018 India Phone 9242753747 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Jagannath Purushothama Designation Assistant Professor Affiliation Nitte University, Mangaluru, India Address Department of Public Health, K S Hegde Medical Academy, Deralakatte, Mangaluru Univeristy Complex, Nitte University, Deralakatte, Mangaluru Dakshina Kannada

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KARNATAKA 575018 India Phone 9242753747 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > K S Hegde Medical Academy, Deralakatte, Mangaluru 575018 Primary Sponsor Primary Sponsor Details Name K S Hegde Medical Academy Address Department of Public Health Deralakatte Mangaluru 575018 Type of Sponsor Private medical college Details of Secondary Name Address Sponsor K S Hegde Medical Academy Deralakatte, Mangaluru, Karnataka 575018 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Jagannath P Wenlok Hospital Attavara, Mangaluru 9242753747 575001 Dakshina Kannada [email protected] KARNATAKA n Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 08/08/2017 No Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Tuberculosis of lung Intervention / Type Name Details Comparator Agent Intervention Experimental Group Behavioral therapy- Once a month for 3 months; nicotine chewing gums- 2 mg, 6 times a day for 3 months Comparator Agent Control Group Behavioral therapy- Once a month for 3 months; sugar-free mint flavoured chewing gums, 6 times a day for 3 months (Placebo) Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details Pulmonary Tuberculosis patients registered for DOTS with a history of smoking tobacco. Exclusion Criteria Exclusion Criteria Details Smokeless-only Tobacco Users Pregnant Women

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Method of Generating Permuted block randomization, fixed Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Participant Blinded Primary Outcome Outcome Timepoints Smoking Cessation among the participants 6 months Secondary Outcome Outcome Timepoints Reduction in smoking 1 month Target Sample Size Total Sample Size=300 Sample Size from India=300 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 14/11/2018 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=2 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details None yet Brief Summary Background:

Tuberculosis (TB) and tobacco smoking are currently two formidable public health concerns and independently pose a considerable threat to global health. The current estimates put the annual global mortality from the two epidemics at over six million. It is remarkable to note that TB and tobacco use are co-prevalent in many developing nations and these nations are said to be doubly burdened by the collision of the two epidemics. In addition, there is substantial and overwhelming evidence to conclude that smoking is strongly linked to TB disease and leads to poor treatment outcomes. It is consistently reported also that the prevalence of smoking among TB patients was high when compared with non-TB controls or the general population.

It is also well documented that tobacco smoking suppresses both cell- and humoral-mediated immunity thereby causing TB infection and worsening the outcomes of treatment. However, most of the immunological abnormalities induced by smoking including decreased level of circulating

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immunoglobulins, decreased ratio of CD4+ to CD8+ lymphoctyes, and decreased release of proinflammatory cytokines are reversible within six weeks after smoking cessation. Thus, it is strongly recommended that smoking cessation using both cognitive behavioral therapy and pharmacotherapeutic approach be incorporated as a standard of care in directly observed therapy short-course (DOTS) and other TB treatment strategies.1

Research Question: What is the effectiveness of smoking cessation

among experimental and control group of pulmonary tuberculosis patients

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undergoing directly observed therapy- short course?

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Null Hypothesis: There is no difference in the smoking quit rates between

the experimental group and the control group.

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Alternate hypothesis: There is a difference in the smoking quit rates

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between the experimental group and the control group.

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Primary objective: To determine the effectiveness of smoking cessation

among the experimental and control group of pulmonary tuberculosis

patients undergoing Directly Observed Therapy- Short Course

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Secondary objectives:

• To determine the relationship between smoking cessation and tuberculosis treatment outcome between the study group and the control group • To assess the factors influencing the effectiveness of smoking cessation among the study participants • To develop a new framework for joint TB-Tobacco collaborative activities in relation to smoking cessation.

Material and methods:

Study design: The study will be a randomized controlled study.

Study area: Tobacco Cessation Centre at Wenlock Hospital, Mangaluru, Dakshina Kannada.

Reference population: All cases of pulmonary tuberculosis who currently smoke tobacco in any form.

Study population: Current tobacco smokers diagnosed as pulmonary tuberculosis patients registered as Category I and Category II cases for DOTS regimen.

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Study period: November 2018 to December 2019.

Study method:

Randomization: Block Randomization will be done to obtain the two groups using a permuted method

Experimental group: Study participants will be given nicotine replacement therapy and brief advice

Control group: Study participants will be given “Brief Advice” as per National Framework for joint TB-Tobacco collaborative activities.

Placebo for control group: Sugar-free chewing gum

Blinding: The trial will be single-blinded wherein the participant will not be aware of the group that they belong to.

The sample size for each arm is 150

Data Collection:

• Structured/semi-structured questionnaire

• Enrolment of participants into study group and control group by randomization. • Self-administered questionnaire: Demographic details of the participant, tobacco use status, history of smoking, current status of smoking will be obtained using a self administered questionnaire. • Case history sheet: To record the intervention details and follow-up details of the experimental group. • Fagerstorm Scale for Tobacco Dependence: Baseline information from both the experimental group and control group. • Transtheoritical model for smoking cessation

• Carbon Monoxide Monitor: To analyze exhaled CO level of participants from both the groups. • Urine cotinine test: Biomarker for nicotine dependence

• In-depth interview of 6 stakeholders to develop a Programme Implementation Plan for integration of RNTCP and National

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Tobacco Control Programme in relation to smoking cessation.

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