| CTRI Number |
CTRI/2025/02/080199 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
MELATONIN IN PREVENTION OF DELIRIUM
|
|
Scientific Title of Study
|
ROLE OF MELATONIN IN PREVENTION AND
MANAGEMENT OF DELIRIUM IN CRITICALLY ILL PATIENTS:
A PROSPECTIVE, PLACEBO CONTROLLED 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 |
Dr Harshita Tiwari |
| Designation |
Junior Resident |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY |
| Address |
Department of Psychiatry, Jawaharlal Nehru Medical College, Aligarh Muslim University
department of Psychiatry, Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8303640179 |
| Fax |
|
| Email |
harshitatiwari3009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. R. K. Gaur |
| Designation |
Professor |
| Affiliation |
ALIGARH MUSLIM UNIVERSITY |
| Address |
Department of Psychiatry, Jawaharlal Nehru Medical College, Aligarh Muslim University
Department of Psychiatry, Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837120329 |
| Fax |
|
| Email |
rkg_amu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr FAISAL SHAAN |
| Designation |
Assistant Professor |
| Affiliation |
Department of Psychiatry, Jawaharlal Nehru Medical College, AMU Campus |
| Address |
Department of Psychiatry, Jawaharlal Nehru Medical College, AMU Campus, Medical Road, Aligarh, UTTAR PRADESH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9557802038 |
| Fax |
|
| Email |
faisal.shaan5@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.N MEDICAL COLEGE HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr Harshita Tiwari |
| Address |
Department of Psychiatry
Jawaharlal Nehru Medical College
Aligarh Muslim University, Aligarh
202002 |
| 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 |
| Dr Harshita Tiwari |
Jawaharlal Nehru Medical College and Hospital |
CCW/ICU of Medicine department, Jawaharlal Nehru Medical College , AMU Campus, Medical Road
Aligarh
UTTAR PRADESH |
8303640179
harshitatiwari3009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.),Jawaharlal Nehru Medical College and Hospital, Faculty of Medicine, Aligarh Muslim University, Aligarh, India - 202002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline |
Normal saline used in single daily dosing through oral/ryles tube(as per patients status) till patient was shifted out of ICU or discharged. |
| Intervention |
Oral melatonin syrup |
Oral melatonin syrup used in single daily dosing through oral/ryles tube (as per patients status) till patient was shifted out of ICU or discharged. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Critically ill patients
Diagnosis of delirium
Anticipitated ICU stay more 48 hours
given written consent |
|
| ExclusionCriteria |
| Details |
ICU admission less than 48 hours
Patient in deep sedation, coma or ventilatory support
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence , severity and improvement in delirium assessed using CAM-ICU and improvemnent in delirium on melatonin use. |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Encompass the duration of delirium , length of stay in the critical care ward (CCW)/ Intensive care unit (ICU) and overall mortality. |
24 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/02/2025 |
| 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="2"
Months="0"
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
|
1. To see the efficacy of melatonin in prevention of delirium in ICU setting. 2. To see the incidence and severity of delirium admitted in ICU. 3. The role of melatonin in the management of delirium. |