| CTRI Number |
CTRI/2024/12/078569 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to know the occurrence and actions taken for Adverse drug reactions in patients admitted for treatment in a multispecialty hospital. |
|
Scientific Title of Study
|
An observational analysis of prevalence of adverse drug reaction in a tertiary care multispecialty hospital. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palak Arya |
| Designation |
PharmD student |
| Affiliation |
Indus International Hospital |
| Address |
Department of clinical trial.
Chandigarh Ambala Highway
Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India |
| Phone |
7988104576 |
| Fax |
|
| Email |
aryapalak944@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parminder Kaur |
| Designation |
Medical Superintendent |
| Affiliation |
Indus International Hospital |
| Address |
Admin Department
Chandigarh Ambala Highway
Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India |
| Phone |
8872735888 |
| Fax |
|
| Email |
msiih@indushospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharmender Singh Lather |
| Designation |
Senior manager clinical trials department |
| Affiliation |
Indus International Hospital |
| Address |
Department of clinical trial.
Chandigarh Ambala Highway
Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India |
| Phone |
9215810327 |
| Fax |
|
| Email |
clinicalmanager@indushospitals.com |
|
|
Source of Monetary or Material Support
|
| Indus international hospital
Clinical trial department
Chandigarh Ambala highway
Derabassi
SAS Nagar
Punjab
India
140507 |
|
|
Primary Sponsor
|
| Name |
Indus international hospital |
| Address |
Clinical trial department
Chandigarh Ambala highway
Punjab 140507 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Palak Arya |
Indus International Hospital |
Department of clinical trial.
Chandigarh Ambala Highway
Derabassi
Rupnagar
PUNJAB |
07988104576
aryapalak944@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indus International Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare, (2) ICD-10 Condition: R50-R69||General symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient hospitalized at IIH for treatment under:
Surgical ward
Oncology ward
Executive ward
FICU
Private ward
Medical ward. |
|
| ExclusionCriteria |
| Details |
Patient below 18
HIV Patient and leprosy
LAMA cases
Medico legal cases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occurrence of adverse drug reaction at each phase of medication cycle. |
At discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Awareness of Adverse drug reaction in each phase of medication use cycle. |
Post discharge. |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "500"
Final Enrollment numbers achieved (India)="500" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2024 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
World Health Organization (WHO) defines an adverse drug reaction (ADR) as “one which is noxious and unintended, and which occurs in doses normally used in human for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological functions.†According to the Centre for Health Policy Research, more than 50 percent of the approved drugs in the United States were associated with some type of adverse effect not detected prior to approval. At least one ADR has been reported to occur in 10 to 20% of hospitalized patients. Pharmacovigilance or ADR monitoring, launched by WHO in the 1960s in the wake of ‘thalidomide’ disaster, is currently an integrated global effort of more than 70 countries worldwide. After the “thalidomide tragedy†many countries have established drug monitoring systems for early detection and prevention of possible drug-related morbidity and mortality. The use of traditional and complementary drugs (e.g. herbal remedies) may also pose specific toxicological problems, when used alone or in combination with other drugs |