| CTRI Number |
CTRI/2024/07/071259 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Potential
Drug-Drug Interactions in Patients Attending
Medicine OPD in a Tertiary Care Hospital
|
|
Scientific Title of Study
|
Evaluation of Potential
Drug-Drug Interactions in Patients Attending
Medicine OPD 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 |
Department of Pharmacology
2nd Floor Academic Building
R G kar Medical College and Hospital
1 Khudiram Bose Sarani Kolkata WEST BENGAL India
Kolkata
WEST BENGAL
700004
India
Kolkata
WEST BENGAL
700004
India |
| Phone |
6290918629 |
| Fax |
|
| Email |
gunjangayen75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lopamudra Dhar Chowdhury |
| Designation |
Professor Department of Pharmacology |
| Affiliation |
R G Kar Medical College and Hospital |
| Address |
Department of Pharmacology
2nd floor Academic building
R G Kar Medical College and Hospital
1 Khudiram Bose Sarani
Kolkata
West Bengal
Kolkata
WEST BENGAL
700004
India |
| Phone |
8910607290 |
| Fax |
|
| Email |
drlopamudra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lopamudra Dhar Chowdhury |
| Designation |
Professor Department of Pharmacology |
| Affiliation |
R G Kar Medical College and Hospital |
| Address |
Department of Pharmacology
2nd floor Academic building
R G Kar Medical College and Hospital
1 Khudiram Bose Sarani
Kolkata
West Bengal
WEST BENGAL
700004
India |
| Phone |
8910607290 |
| Fax |
|
| Email |
drlopamudra@hotmail.com |
|
|
Source of Monetary or Material Support
|
| R G Kar Medical College and Hospital
1 Khudiram Bose Sarani
Kolkata 700004
West Bengal
India |
|
|
Primary Sponsor
|
| Name |
R G Kar Medical College and Hospital |
| Address |
1 Khudiram Bose Sarani
Kolkata 700004
West Bengal
India |
| 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 and Hospital |
Department of Medicine,
1st floor, OPD Building
R G Kar Medical College and Hospital
1 Khudiram Bose Sarani
Kolkata 700004
WEST BENGAL
Kolkata
WEST BENGAL |
6290918629
gunjangayen75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee R G Kar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z922||Personal history of drug therapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age above 18 years attending
Medicine OPD
2. 2 or more drugs prescribed
|
|
| ExclusionCriteria |
| Details |
1. Drug abuse
2. Patients with poor adherence to therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Understanding of drug- drug interaction can enable precision medicine by promoting the rational development of combination therapy
|
baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Knowledge of drug-drug interaction will help healthcare professionals to be aware of its adverse impact on health and to prevent it.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="267"
Sample Size from India="267"
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)
|
05/08/2024 |
| 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
|
Patients above 18 years of age attending Medicine OPD of R G Kar Medical College & Hospital, having
given proper consent and the fulfillment of inclusion and exclusion criteria are taken into account in the study. Drug-drug interactions will be checked for prescriptions with 2
or more drugs. Potential Drug-drug interactions will be documented in case
record form prepared according to the data requirements of the study which includes the patient’s demographic
details, drugs prescribed, Drug-drug interaction mechanism categorization, consequences and it’s
severity. Descriptive statistics will be utilized for the expression of data. The P
value of < 0.05 will be considered statistically significant at 95
confidence interval. All the analysis will be done
by using SPSS software, Graphpad prism etc. |