| CTRI Number |
CTRI/2009/091/000962 [Registered on: 14/12/2009] |
| Last Modified On: |
29/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of Doctors advice to stop smoking in TB and HIV patients |
Scientific Title of Study
Modification(s)
|
Study to evaluate the effect of Physicians advice in quitting smoking in HIV and TB patients in South India - A Pilot study |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2007014 |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrSRameshkumar |
| Designation |
|
| Affiliation |
National Institute for Research in Tuberculosis |
| Address |
Ward 62 (Upstairs)
Government Rajaji Hospital
Madurai
TAMIL NADU
625020
India |
| Phone |
04522534351 |
| Fax |
04428362528 |
| Email |
drrameshskumar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrSRameshkumar |
| Designation |
|
| Affiliation |
National Institute for Research in Tuberculosis |
| Address |
Ward 62 (Upstairs)
Government Rajaji Hospital
Madurai
TAMIL NADU
625020
India |
| Phone |
04522534351 |
| Fax |
04428362528 |
| Email |
drrameshskumar@yahoo.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrSRameshkumar |
| Designation |
|
| Affiliation |
National Institute for Research in Tuberculosis |
| Address |
Ward 62 (Upstairs)
Government Rajaji Hospital
Madurai
TAMIL NADU
625020
India |
| Phone |
04522534351 |
| Fax |
04428362528 |
| Email |
drrameshskumar@yahoo.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| Fogarty AIDS International Training and Research Program (D43-TW000237) funded by U.S.National Institutes of Health |
|
Primary Sponsor
Modification(s)
|
| Name |
Tuberculosis Research Centre |
| Address |
National Institute for Research in Tuberculosis(Formerly Tuberculosis Research Centre)
ICMR,
No 1 Sathyamoorthy road Chetpet Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.S.Ramesh Kumar |
Madurai, Subcentre of Tuberculosis Research Centre |
Ward 62,Government Rajaji Hospital-625020
Madurai
TAMIL NADU |
04522534351
04428362528
drrameshskumar@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, (2) ICD-10 Condition: A150||Tuberculosis of lung, (3) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Counseller's counselling and brochures provision |
|
| Intervention |
Physicians advice |
Brief advise on smoking cessation explaining the problems of smoking with thier disease TB or HIV |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
HIV group:
Inclusion criteria
1. HIV positive (ELISA / Rapid test - Reactive)
2. May or may not have TB.
3. Eighteen years or older
4. Willing to give informed consent
5. Current Smoker
6. Willing to undergo carbon monoxide monitor test
TB group:
Inclusion criteria
1. Newly detected pulmonary tuberculosis (Sputum AFB - positive)
2. Eighteen years or older
3. Willing to give informed consent
4. Current Smokers
5. Willing to undergo carbon monoxide monitor test
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria(both HIV and TB group)
1. People who do not understand Tamil language.
2. People who have idea of relocating to another geographic area within the study period
3. Severely ill / moribund status
|
|
Method of Generating Random Sequence
Modification(s)
|
Stratified block randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Smoking Cessation |
1 month after intervention |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
15/03/2010 |
| Date of Study Completion (India) |
29/03/2012 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |