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CTRI Number  CTRI/2022/11/047051 [Registered on: 04/11/2022] Trial Registered Prospectively
Last Modified On: 03/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A SEARCH TO IDENTIFY ANY DRUG-DRUG INTERACTION AMONG PSYCHIATRY INPATIENTS IN A TERTIARY HEALTHCARE CENTRE  
Scientific Title of Study   A STUDY TO IDENTIFY POTENTIAL DRUG-DRUG INTERACTION AMONG PSYCHIATRY INPATIENTS IN A TERTIARY HEALTHCARE CENTRE  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nisha Rajesh 
Designation  student 
Affiliation  NGSM Institute of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice, NGSMIPS, Paneer, Deralakatte, Mangaluru Dakshina kannada KARNATAKA-575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7760936568  
Fax    
Email  nshammi10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Juno J Joel 
Designation  Assistant professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSMIPS, Paneer, Deralakatte, Mangaluru Dakshina kannada KARNATAKA-575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9480470727  
Fax    
Email  junojoel@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Smitha  
Designation  Assistant professor 
Affiliation  K S Hegde Medical Academy 
Address  Department of Psychiatry, Justice K S Hegde charitable hospital Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9241188486  
Fax    
Email  drsmitha9@nitte.edu.in  
 
Source of Monetary or Material Support  
NGSM institute of Pharmaceuticaal Sciences Mangaalore 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Juno J Joel  Justice KS Hegde Charitable Hospital, Nitte (Deemed to be University)  Department of Psychiatry, 6th floor, Deralakatte, Mangalore-575002 Dakshina kannada, KARNATAKA
Dakshina Kannada
KARNATAKA 		 9480470727

junojoel@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F068||Other specified mental disorders due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Participants of either gender, age 18 years or above, admitted in the department of psychiatry, prescribed with at least two drugs(one of which was from the psychotropic class).
All the participants with a psychiatric diagnosis as per the Tenth Revision of the International Classification of Diseases (ICD 10)
 
 
ExclusionCriteria 
Details  Participants referred to the psychiatric unit for evaluation.
Participants or guardian not willing to give consent.
Topical agents and drugs which were not included in any of the reference resources.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to determine the drugs associated with significant drug-drug interactions and the symptoms related to them  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
• The information from the results can be used by the healthcare workers for better understanding of drug-drug interactions occurring in the psychiatric patients and avoid the same in the future  Baseline 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   09/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION:

The term "drug-drug interaction" is an adverse drug event that can be defined as a process that occurs when two or more drugs are administered in such a way that can cause an interruption to the desired pharmacological activity of any of the administered drug thereby causing clinically undesirable changes to the drug’s action in a body.

OBJECTIVE OF THE STUDY:

To identify the potential drug-drug interactions among prescriptions of psychiatric inpatients and to detect any possible symptoms associated with these drug-drug interactions.

METHODOLOGY:

A prospective observational study will be conducted for a duration of 6 months among participants of either gender aged above 18 years with psychiatry disorder prescribed with at least two drugs(one of which is from the psychotropic class). A well designed data collection form will be used to collect the required data. Drug interaction will be identified using an appropriate software, Stockley’s drug interaction textbook.

STATISTICAL ANALYSIS:

Statistical analysis of the data will be done using SPSS 23.0 at 95% confidence level. Data will be expressed as descriptive statistics, meanS.D or frequency(%) and  will be analysed using Chi Square test to check for the association between patient demography and occurrence of pDDIs.

 

OUTCOME MEASURES:

This study will help to determine the drugs associated with significant drug-drug interactions with respect to the severity and address the symptoms that accompanies them. The findings will serve as a guide for healthcare professionals by appraising the need for attention required to be given for possible and preventable drug-drug interactions that can occur among the psychiatric patients in the future.


 
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