| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
|
|
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. |