| CTRI Number |
CTRI/2025/08/092317 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
study is looking at how common diabetes is among people who also have tuberculosis in Cental India, what factors might make someone more likely to have both conditions,and how well they respond to tuberculosis tretament. |
|
Scientific Title of Study
|
A study on prevalence of Diabetes Mellitus, determinants and treatment outcomes among patients of tuberculosis in central India. |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Manikpure |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta meghe Institute of higher Education and research |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of higher education and Research Centre, Sawangi Meghe, Wardha
Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of higher education and Research Centre, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8956146985 |
| Fax |
|
| Email |
Shubhammanikpure1507@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhishek Ingole |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Datta meghe Institute of higher Education and research |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of higher education and Research Centre, Sawangi Meghe, Wardha
Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of higher education and Research Centre, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9423889135 |
| Fax |
|
| Email |
ingole.abhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Manikpure |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta meghe Institute of higher Education and research |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of higher education and Research Centre, Sawangi Meghe, Wardha
Department of Community Medicine, Jawaharlal Nehru Medical College, Datta Meghe Institute of higher education and Research Centre, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
08956146985 |
| Fax |
|
| Email |
Shubhammanikpure1507@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India, 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha Maharashtra, India, 442001 |
| 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 |
| Shubham Manikpure |
Acharya Vinoba Bhave Rural Hospital |
Department of Respiratory Medicine, ground floor, AVBRH building Sawangi Meghe
Wardha
MAHARASHTRA |
8956146985
shubhammanikpure1507@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E13||Other specified diabetes mellitus, (2) ICD-10 Condition: A159||Respiratory tuberculosis unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged more than 18 years Diagnosed with Tuberculosis of all categories
2. Patients registered for treatment of TB at the DOTS Centre in AVBRH Sawangi and the DOTS Centre of the civil hospital in Wardha.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of diabetes mellitus among tuberculosis patients registered for treatment under DOTS centre in central India |
Assessment will be done at 2nd, 4th and 6th months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlations of tuberculosis and diabetes treatment outcomes, identifying potential risk factor associated with diabetes in tuberculosis and to compare the treatment outcomes for tuberculosis among diabetes and non-diabetics |
Assessment will be done at 2nd, 4th and 6th months. |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
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)
|
16/09/2025 |
| 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
|
TB infection is the serious problem whole world is facing currently. It
is one of the major causes for both the things morbidity and mortality. Malnutrition,
smoking, overcrowding and other immune-suppressing virus that is HIV plays a
big role in its pathogenicity. The causative agent of TB that is
Mycobacterium Tuberculosis is the most hazardous pathogen which was discovered.
In the past it was know to be disease of poverty affecting low socio economic
background population. this will be a propsective study conducted in civil hospital and AVBRH hospital of Wardha district. A total of 216 patients will be enrolled. this study aims to find the prevalence
of Diabetes Mellitus, determinants and treatment outcomes among patients of
Tuberculosis in Central India. |