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CTRI Number  CTRI/2023/07/055276 [Registered on: 17/07/2023] Trial Registered Prospectively
Last Modified On: 15/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Monitoring of side effects of drugs in psychiatric patients 
Scientific Title of Study   Monitoring of Adverse drug reactions in the psychiatric department of tertiary care hospital  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abdul Basith 
Designation  Student 
Affiliation  Karavali College of Pharmacy 
Address  Department of Pharmacy Practice, Karavali College of Pharmacy, Vamanjoor, Mangalore.

Dakshina Kannada
KARNATAKA
575028
India 
Phone  9902379317  
Fax    
Email  basith9317@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Grinton Josvi Veigas 
Designation  Assistant Professor 
Affiliation  KARAVALI COLLEGE OF PHARMACY, VAMANJOOR, MANGALORE 
Address  Department of Pharmacology, Karavali College of Pharmacy, Vamanjoor, Mangalore.

Dakshina Kannada
KARNATAKA
575028
India 
Phone  9901751579  
Fax    
Email  grin2veigas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Grinton Josvi Veigas 
Designation  Assistant Professor 
Affiliation  KARAVALI COLLEGE OF PHARMACY, VAMANJOOR, MANGALORE 
Address  Department of Pharmacology, Karavali College of Pharmacy, Vamanjoor, Mangalore.

Dakshina Kannada
KARNATAKA
575028
India 
Phone  9901751579  
Fax    
Email  grin2veigas@gmail.com  
 
Source of Monetary or Material Support  
Father Muller Medical College Hospital, Mangalore, Karnataka. 
 
Primary Sponsor  
Name  Abdul Basith 
Address  Department of Pharmacy Practice, Karavali College of Pharmacy, Vamanjoor, Mangalore, Karnataka - 575028 
Type of Sponsor  Other [Self] 
 
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 
Grinton Josvi Veigas  Father Muller Medical College Hospital  Father Muller Medical College Hospital
Dakshina Kannada
KARNATAKA 
9901751579

grin2veigas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F99||Mental disorder, not otherwise specified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  patients admitted with diagnosis of psychiatric conditions 
 
ExclusionCriteria 
Details  pregnant and lactating women
paediatric patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will give an overview of occurrence of adverse drug reactions among the psychiatric patients during treatment process.  15 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="199"
Sample Size from India="199" 
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)   24/07/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The world health organization (WHO) has defined adverse drug reaction (ADR) as ’A response to a drug which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function’. Hospitals are required to evaluate, monitor, and respond to adverse drug reactions (ADRs) in order to obtain accreditation by the joint commissions. Neurotic disorders, psychosis, alcohol/drug addiction, mental retardation and epilepsy are common mental and behavioral disorder in India. Most mental illness require medications for longer duration ranging from several months to years. Because of longer duration of therapy wide range of adverse drug reactions (ADRs) are associated which can lead to long compliments and, or discontinuation of therapy. The wide variation in the clinical response to a standard dose of an antidepressant drug is due to inter and intra individual difference in pharmacokinetics and pharmacodynamics. Under the same dose, some patients respond, others suffer from the poor efficacy or experience toxic effects. The purpose of this study is to employ a mechanistic approach to prospectively investigate the incidence of ADRs in psychiatric inpatients population.
 
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