| CTRI Number |
CTRI/2024/04/065185 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Status of tuberculosis patients in India |
|
Scientific Title of Study
|
Assessment of the status of presentation and management of tuberculosis patients in Tertiary Care centre. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swarupa Chakole |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of community medicine, Jawaharlal Nehru Medical College,Sawangi , Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7583836565 |
| Fax |
|
| Email |
drswarupachakole@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swarupa Chakole |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of community medicine, Jawaharlal Nehru Medical College,Sawangi , Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7583836565 |
| Fax |
|
| Email |
drswarupachakole@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swarupa Chakole |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of community medicine, Jawaharlal Nehru Medical College,Sawangi , Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7583836565 |
| Fax |
|
| Email |
drswarupachakole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College,DMIHER Campus, Sawangi (Meghe) Wardha |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical Sciences, Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi(M), Wardha
Maharashtra |
| Type of Sponsor |
Private medical college |
|
|
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 Mitul Saha |
Jawaharlal Nehru Medical College |
Department of community Medicine, 3rd floor JNMC building, Sawangi (M) Wardha
Wardha
MAHARASHTRA |
7695015373
27mitulsaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Datta Meghe Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Recentlly diagnosed sputum positive tuberculosis patients.
2.patients attending OPD or admitted in Tuberculosis centres. |
|
| ExclusionCriteria |
| Details |
1. Bed ridden critical tuberculosis patient .
2. Cured tuberculosis patient without any present infection.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
No. of days of delay in tuberculosis patient presentation
no. of days of delay in diagnosis and management
determinants of delay
|
data will be assessed at the end of 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| derminants of delay in presentation , managemnet and delay in tuberculosis patients |
data will be analysed by end of 24 mont |
|
|
Target Sample Size
|
Total Sample Size="377"
Sample Size from India="377"
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 Enrollment (India)
|
19/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tuberculosis (TB) continues to pose a
notable public health issue not just within India but on a worldwide scale.
Analyzing the causes of presentation,
management, and treatment delays of tuberculosis can offer valuable
understanding into local trends and aid in crafting specific approaches for the
successful management of TB. This
research involves a cross-sectional examination conducted among TB patients
residing in the regions served by the District Tuberculosis Centre, Wardha, and the directly observed treatment short course
center in Sawangi. Information will be collected using a standardized
questionnaire endorsed by the World Health Organization. |