| CTRI Number |
CTRI/2019/08/020968 [Registered on: 29/08/2019] Trial Registered Prospectively |
| Last Modified On: |
11/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Nicotine Replacement Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECTIVENESS OF BEHAVIORAL COUNSELLING VERSUS BEHAVIOURAL COUNSELLING WITH NICOTINE GUM ALONE FOR QUITTING TOBACCO USAGE AMONG TUBERCULOSIS PATIENTS VISITING DOTS CENTRES, DELHI.
|
|
Scientific Title of Study
|
EFFECTIVENESS OF TWO METHODS OF TOBACCO CESSATION AMONG TUBERCULOSIS PATIENTS VISITING DOTS CENTRES, DELHI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SNEHA MALHOTRA |
| Designation |
Post Graduate Student |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Public Health Dentistry ,Maulana Azad Institute of Dental Sciences, MAMC campus,New Delhi
Central
DELHI
110002
India |
| Phone |
09711313558 |
| Fax |
|
| Email |
snehamalhotra16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikrant Mohanty |
| Designation |
Associate Professor and Head Of Department , Public Health Dentistry |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Public Health Dentistry ,Maulana Azad Institute of Dental Sciences, MAMC campus New Delhi
Central
DELHI
110002
India |
| Phone |
09654700983 |
| Fax |
|
| Email |
vikrantmohanty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SNEHA MALHOTRA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Public Health Dentistry ,Maulana Azad Institute of Dental Sciences, MAMC campus,New Delhi
New Delhi
DELHI
110002
India |
| Phone |
09711313558 |
| Fax |
|
| Email |
snehamalhotra16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry, Maulana Azad Institute of Dental
Sciences(Govt. of NCT Delhi), B.S. Z-Marg, MAMC Campus New Delhi-
110002 |
|
|
Primary Sponsor
|
| Name |
SNEHA MALHOTRA |
| Address |
Department of public health dentistry ,Maulana Azad Institute of Dental Sciences, MAMC campus, New Delhi, DELHI 110002 India |
| Type of Sponsor |
Other [PERSONAL] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ICMR |
Dr. N. C. Jain, Scientist G & Head (HRD), Indian Council of Medical Research, Ansari Nagar, Post Box No. 4911, New Delhi-110029 |
| RNTCP |
State TB Cell, RNTCP, Delhi, Health Centre Building,Delhi Govt. Colony; GULABI BAGH, Delhi-110007 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SNEHA MALHOTRA |
Delhi Government Dispensary, Gokulpuri. |
Ground floor, Delhi Government Dispensary, Main Market, A-Block, Gokulpuri, New Delhi, Delhi-110094, India
North East
DELHI |
09711313558
snehamalhotra16@gmail.com |
| SNEHA MALHOTRA |
Tuberculosis chest clinic at Lok Nayak Hospital |
Ground floor, Lok Nayak Hospital, Near Delhi Gate Metro Station, Jawaharlal Nehru Marg, Delhi Gate, New Delhi-110001
Central
DELHI |
09711313558
snehamalhotra16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| MAIDS Ethical Committee |
Approved |
| Tuberculosis Chest Clinic Lok Nayak Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, (2) ICD-10 Condition: A154||Tuberculosis of intrathoracic lymph nodes, (3) ICD-10 Condition: F172||Nicotine dependence, (4) ICD-10 Condition: A155||Tuberculosis of larynx, trachea and bronchus, (5) ICD-10 Condition: A156||Tuberculous pleurisy, (6) ICD-10 Condition: A157||Primary respiratory tuberculosis, (7) ICD-10 Condition: A158||Other respiratory tuberculosis, (8) ICD-10 Condition: A159||Respiratory tuberculosis unspecified, (9) ICD-10 Condition: A170||Tuberculous meningitis, (10) ICD-10 Condition: A171||Meningeal tuberculoma, (11) ICD-10 Condition: A178||Other tuberculosis of nervous system, (12) ICD-10 Condition: A179||Tuberculosis of nervous system, unspecified, (13) ICD-10 Condition: A180||Tuberculosis of bones and joints, (14) ICD-10 Condition: A181||Tuberculosis of genitourinary system, (15) ICD-10 Condition: A182||Tuberculous peripheral lymphadenopathy, (16) ICD-10 Condition: A182||Tuberculous peripheral lymphadenopathy, (17) ICD-10 Condition: A183||Tuberculosis of intestines, peritoneum and mesenteric glands, (18) ICD-10 Condition: A184||Tuberculosis of skin and subcutaneous tissue, (19) ICD-10 Condition: A185||Tuberculosis of eye, (20) ICD-10 Condition: A186||Tuberculosis of (inner) (middle) ear, (21) ICD-10 Condition: A187||Tuberculosis of adrenal glands, (22) ICD-10 Condition: A188||Tuberculosis of other specified organs, (23) ICD-10 Condition: A190||Acute miliary tuberculosis of a single specified site, (24) ICD-10 Condition: A191||Acute miliary tuberculosis of multiple sites, (25) ICD-10 Condition: A192||Acute miliary tuberculosis, unspecified, (26) ICD-10 Condition: A198||Other miliary tuberculosis, (27) ICD-10 Condition: A199||Miliary tuberculosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Behavioral
counselling,
Nicotine
Replacement
Therapy |
NRT Dosage 2mg and 4 mg depending upon the
patients tobacco usage. Route of administration -
Oral Total duration- 12 weeks. Schedule- For first
6 weeks- One Gum every 1-2 hours For 6- 10
weeks - One Gum every 2-4 hours For 10-12
weeks - One Gum every 4-8 hours or when
craving occurs. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) All Pulmonary (smear positive and smear negative) and Extrapulmonary Tuberculosis Patients reporting to the Tuberculosis centres, consuming tobacco in any form.
2) All aged more than 18 years of either sex.
|
|
| ExclusionCriteria |
| Details |
1) Patients having multi-drug resistant tuberculosis at diagnosis.
2) Patients who are medically compromised and have diseases which are contraindications for NRT use.
3) Patients who have received tobacco cessation counselling in the past.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of two methods on the basis of quit status: quit, reduction and status quo. |
1st week, 1st month, 3rd month, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare biochemically verified cotinine levels using qualitative tests, to measure nicotine dependence and to know the predictors of tobacco cessation among tuberculosis patients |
1st Week, 1st Month, 3rd Month, 6th Month |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/09/2019 |
| Date of Study Completion (India) |
18/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
SUMMARY
The present study was a randomized clinical trial conducted with the aim to assess the to assess the effectiveness of
two methods of tobacco cessation among tuberculosis patients visiting DOTS
centres, Delhi.
To summarise the
findings of the present study following points can be taken into
considerations:
1.
A
total of 90 study subjects who used tobacco products in any form, were included
in the study, Group A consisted of 45 in behavioural counselling group and
Group B consisted of 45 in the behavioural counselling and Nicotine Replacement
Therapy.
2.
The
study comprised of 95.6% male subjects and 2.2% female
subjects. Majority of them belonged to the upper
lower socioeconomic status.
3.
Out
of 90 subjects, 40% are of the age Group 18-29 years
in Group A, whereas, the Group B consist of 28.9% of age Group 18-29 years.
4.
Pulmonary TB was
diagnosed in 82.2% of the subjects in Group A and 62.2% in Group B were
diagnosed with Pulmonary TB patients.
5.
Smoke
form of tobacco was used by 24.4% study subjects in Group A and 13.3% in Group B.
Smokeless form of tobacco was used among 55.6% and 48.9%
study subjects in Group A and Group B respectively.
6.
Out of 45 subjects in
Group A, (46.7%) had initiated tobacco use at an age between 15-20 year. In
Group B, nearly 19 (42.2%) had initiated tobacco use at the same age as Group
A. A dominant reason for initiation of
tobacco was peer pressure.
7.
Previous
quit attempts were not made by 97.8% study subjects in
Group A and by 91.1%
study subjects in Group B.
8.
With the help of
behavioural counselling alone 57.8% study subjects were successful in quitting
tobacco and 80% subjects
had quit the habit with the use of Nicotine
Replacement Therapy along with behavioural counselling after 6 months
follow up period.
|