| CTRI Number |
CTRI/2024/07/069753 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Monitoring Side Effects of Tuberculosis and HIV Medications: Understanding side effects in Patients on ATT and ART for Better Treatment
|
|
Scientific Title of Study
|
Adverse Drug Reaction monitoring in Patients receiving Anti Tubercular ( ATT ) and Antiretroviral Therapy ( ART ) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puneet Paliwal |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal nehru medical college a.m.u |
| Address |
Department of Pharmacology
Jawaharlal nehru medical college
Aligarh muslim university
Aligarh Uttar Pradesh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8130811485 |
| Fax |
|
| Email |
puneetpaliwal23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Ziaur Rahman |
| Designation |
Professor |
| Affiliation |
Jawahar lal nehru medical college and hospital |
| Address |
Department of Pharmacolgy
Jawaharlal nehru medical college
Aligarh muslim university
Aligarh Uttar Pradesh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8266001772 |
| Fax |
|
| Email |
rahmansz@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syed Ziaur Rahman |
| Designation |
Professor |
| Affiliation |
Jawahar lal nehru medical college and hospital |
| Address |
Department of Pharmacolgy
Jawaharlal nehru medical college
Aligarh muslim university Aligarh Uttar Pradesh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8266001772 |
| Fax |
|
| Email |
rahmansz@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal nehru medical college and hospital Aligarh muslim university Aligarh
Uttar Pradesh 202002 |
|
|
Primary Sponsor
|
| Name |
Dr Puneet Paliwal |
| Address |
Department of pharmacology
jawahar lal nehru medical college aligarh , aligarh muslim university medical road
aligarh, uttar pradesh . 202002 |
| Type of Sponsor |
Other [self] |
|
|
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 Syed Ziaur Rahman |
Jawaharlal medical college and hospital university |
Department of pharmacology and Department of TB and chest
Jawaharlal nehru medical college and hospital
aligarh muslim university
aligarh uttarpradesh 202002
Aligarh
UTTAR PRADESH |
8266001772
rahmansz@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Regd. ) Jawaharlal nehru medical college and hospital, faculty of medicine, aligarh muslim university, aligarh , india, 202002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, (2) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases of adverse drug reactions due to anti-tubercular and antiretroviral therapy.
2.Patients more than 18 years with Pulmonary TB, EPTB or disseminated TB.
|
|
| ExclusionCriteria |
| Details |
1.Cases having incompletely filled adverse drug reaction details will be excluded from the study.
2.Treatment defaulters or death within 15 days of ATT.
3.Any other diagnosis other than TB after starting treatment.
4.Cases who do not give consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the frequency of adverse drug reactions in patients receiving anti-tubercular ( ATT ) and antiretroviral drugs ( ART ) every 4 to 6 weeks.
2.To study the nature of adverse drug reactions in Patients receiving anti-tubercular ( ATT ) and antiretroviral drugs ( ART ) and to characterize ADR according to type , Severity and time of occurrence every 4 to 6 weeks
|
18 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare clinical and therapeutic details in serious and non serious cases of adverse drug reactions due to anti-tubercular and antiretroviral drugs.
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
10/07/2024 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
The study aims to evaluate the adverse drug reaction profile in patients receiving anti-tubercular therapy (ATT) and antiretroviral therapy (ART), focusing on the frequency, nature, and characteristics of these reactions. Conducted as an analytical-cross sectional type/prospective cohort study from Jan 2024 to Jan 2026 in the Departments of Pharmacology and TB & Chest from Jan 2024 to Dec 2025, the study will encompass 600 patients experiencing adverse drug reactions. The justification for this sample size is based on previous research findings. Inclusion criteria involve patients above 18 years with various forms of TB, while exclusion criteria include incomplete data, treatment defaulters, or alternate diagnoses post-treatment initiation. Methodology includes assessing ADR frequency, nature, severity, causality using standardized scales, concurrent medications, and comorbid conditions. |