| CTRI Number |
CTRI/2024/05/067521 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Adverse Drug Reactions in patients receiving
Antiretroviral Therapy |
|
Scientific Title of Study
|
Evaluation OF Adverse Drug Reactions In Patients On
Antiretroviral Therapy Attending Antiretroviral Therapy
Centre In A Tertiary Care Hospital Of Eastern India – A Cross
Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gunjan Gayen |
| Designation |
Post Graduate Trainee |
| Affiliation |
R.G. Kar Medical College And Hospital |
| Address |
1 Khudiram Bose Sarani
Kolkata
West Bengal
North Twentyfour Parganas
WEST BENGAL
700004
India |
| Phone |
6290918629 |
| Fax |
|
| Email |
gunjan.gayen93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tapas Bera |
| Designation |
Professor and Head Department of Pharmacology |
| Affiliation |
R G Kar Medical College And Hospital |
| Address |
1 Khudiram Bose Sarani
Kolkata
West Bengal
North Twentyfour Parganas
WEST BENGAL
700004
India |
| Phone |
6290918629 |
| Fax |
|
| Email |
drtapasbera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gunjan Gayen |
| Designation |
Post Graduate Trainee |
| Affiliation |
R G Kar Medical College And Hospital |
| Address |
1 Khudiram Bose Sarani
Kolkata
West Bengal
North Twentyfour Parganas
WEST BENGAL
700004
India |
| Phone |
6290918629 |
| Fax |
|
| Email |
gunjan.gayen93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Antiretroviral Therapy Center
R G Kar Medical College And Hospital |
| R G Kar Medical College |
|
|
Primary Sponsor
|
| Name |
Government Medical College |
| Address |
1 Khudiram Bose Sarani
Kolkata 700004
West Bengal |
| 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 Gunjan Gayen |
R G Kar Medical College |
Department of Pharmacology
Antiretroviral Therapy Center
1 Khudiram Bose Sarani
Kolkata 700004
North Twentyfour Parganas
WEST BENGAL |
6290918629
gunjan.gayen93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee R G Kar Medical College And Hospital Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of any gender on Anti Retroviral Therapy
(ART) attending ART Centre.
2) Patients of age above 18 years.
|
|
| ExclusionCriteria |
| Details |
1) Patients who disagree to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Adverse Drug Reactions in Patients on Anti-Retroviral Therapy |
At baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i.To estimate the Severity &
Preventability of ADRs in
patients on ART.
ii. To determine risk factors associated with the ADRs in patients on ART.
iii. To evaluate ADRs in patients with co-infection receiving ART.
iv. To assess whether demographic factors are responsible for the ADRs. |
At baseline
|
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
27/05/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
In this study patients aged above 18 years on Anti
Retroviral Therapy (ART) attending the ART center of R G kar Medical College and
Hospital having given proper consent and fulfilling inclusion and exclusion
criteria are taken into study. Adverse Drug Events occurring during therapy
will be documented in respective Adverse Drug Reaction forms and causality will
be assessed using the WHO-UMC causality categories assessment scale and Naranjo
assessment scale. The severity of the Reaction will be assessed using the Modified
Hartwig and Seigel severity assessment scale. Criteria for preventability will
be assessed using the Schumock and Thronton scale. Expected outcomes in this
study may be as documentation of respective Adverse Drug Reactions in patients
on Antiretroviral Therapy and determination of Severity and Preventability of
ADRs. |