| CTRI Number |
CTRI/2023/10/058874 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
18/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Presentation of patients with Tb lymph node and their response on therapy |
|
Scientific Title of Study
|
Clinical profile and response to treatment of patients with peripheral Tubercular Lymphadenitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Grisha Maich |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 125, 3rd floor, B.L. Taneja block, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9571235525 |
| Fax |
|
| Email |
grisha29grisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Kumar |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 125, 3rd floor, B.L. Taneja block, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9953946064 |
| Fax |
|
| Email |
drnareshmamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Grisha Maich |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 125, 3rd floor, B.L. Taneja block, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9571235525 |
| Fax |
|
| Email |
grisha29grisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital, G.I.P.M.E.R. and G.N.E.C. Hospitals, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital, G.I.P.M.E.R and G.N.E.C. Hospital, New Delhi -110002 |
| Type of Sponsor |
Government 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 GRISHA MAICH |
Lok Nayak and associated Hospitals |
Room no.125, 3rd floor, Medicine department, B. L. Taneja Block, Maulana Azad Medical College, New Delhi
Central
DELHI |
9571235525
grisha29grisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee/ MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A182||Tuberculous peripheral lymphadenopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are newly diagnosed with Tubercular Lymphadenitis on FNAC/Biopsy.
Patients ready to give written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients who are already on Anti Tubercular Therapy. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the clinical characteristics & presentation of patients with peripheral Tubercular Lymphadenitis |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the presence of mycobacterium on ZN staining.
To study the response to treatment at the end of 2 months |
2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/11/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [grisha29grisha@gmail.com].
- For how long will this data be available start date provided 19-10-2024 and end date provided 19-10-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a prospective observational study in which different clinical presentations of patients who are diagnosed with peripheral tubercular lymphadenitis and various affects of anti tubercular drug during intensive phase is observed. |