| CTRI Number |
CTRI/2021/02/030990 [Registered on: 04/02/2021] Trial Registered Prospectively |
| Last Modified On: |
05/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find the presence and related reasons of alcohol use among Tuberculosis patients in Shillong, Meghalaya |
|
Scientific Title of Study
|
A study to assess prevalence and associated factors related to alcoholism among TB patients in Shillong, Meghalaya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ibaiarlin Tham |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room number 62, First floor, Prasanna School of Public Health, Madhav Nagar, Manipal, Udipi, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9366951738 |
| Fax |
|
| Email |
ibaiartham@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
LH-63, First Floor, Prasanna School of Public Health, Manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
kumar.sumit@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ibaiarlin Tham |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room number 62, First floor, Prasanna School of Public Health, Madhav Nagar, Manipal, Udipi, Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9366951738 |
| Fax |
|
| Email |
ibaiartham@gmail.com |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health MAHE |
|
|
Primary Sponsor
|
| Name |
Prasanna School of Public Health MAHE |
| Address |
Room number 63, Prasanna School of Public Health, Madhav Nagar, Manipal, Udupi, Karnataka-576104 |
| Type of Sponsor |
Other [Private Institution of Education and Research] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumit Kumar |
Prasanna School of Public Health |
LH-63, First Floor, Prasanna School of Public Health, Manipal, Udupi, Karnataka
Udupi
KARNATAKA |
8867620088
kumar.sumit@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A15-A19||Tuberculosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
63.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years to 63 years, both genders and who are under supervision |
|
| ExclusionCriteria |
| Details |
Paediatric Tuberculosis cases, participants with medically verified psychological disorders and those who are not willing to give consent |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prevalence of alcohol use and its associated factors among Tuberculosis patients in Shillong |
Three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the prevalence and to identify the associated factors of alcohol use among Tuberculosis patients in Shillong |
Six months to one year |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
Final Enrollment numbers achieved (Total)= "170"
Final Enrollment numbers achieved (India)="170" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/02/2021 |
| Date of Study Completion (India) |
30/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross-sectional study to assess the prevalence and associated factors related to alcoholism among Tuberculosis patients. This study will be conducted in Shillong, Meghalaya. The study will help to know the prevalence of alcoholism and to identify its associated factors among the Tuberculosis patients in Shillong. |