| CTRI Number |
CTRI/2026/01/100537 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Melatonin in Prevention of Delirium in Intensive Care Unit |
|
Scientific Title of Study
|
Efficacy of Melatonin in Prevention of Delirium in Intensive Care Unit: A Prospective Observational 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 DEBASISH GHOSH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
MEDICAL COLLEGE AND HOSPITAL,KOLKATA |
| Address |
Department of Anaesthesiology,
88, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073
Kolkata
WEST BENGAL
700073
India |
| Phone |
9231319202 |
| Fax |
|
| Email |
debasish2801@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Adhishree K |
| Designation |
Post Graduate Resident |
| Affiliation |
MEDICAL COLLEGE AND HOSPITAL,KOLKATA |
| Address |
Department of Anaesthesiology,
88, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073
Kolkata
WEST BENGAL
700073
India |
| Phone |
9087325671 |
| Fax |
|
| Email |
adhikritigai2906@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adhishree K |
| Designation |
Post Graduate Resident |
| Affiliation |
MEDICAL COLLEGE AND HOSPITAL,KOLKATA |
| Address |
Department of Anaesthesiology,
88, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073
Kolkata
WEST BENGAL
700073
India |
| Phone |
9087325671 |
| Fax |
|
| Email |
adhikritigai2906@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MEDICAL COLLEGE AND HOSPITALKOLKATA |
| Address |
88, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073 |
| 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 |
| ADHISHREE K |
MEDICAL COLLEGE AND HOSPITAL,KOLKATA |
CRITICAL CARE UNITS,DEPARTMENT OF ANAESTHESIOLOGY,
88, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073
Kolkata
WEST BENGAL |
9087325671
adhikritigai2906@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH MEDICAL COLLEGE,KOLKATA |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Syrup Melatonin 3mg |
Prophylactic melatonin syrup for prevention of delirium in critical care for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults ( more than 18 years).
Expected ICU stay more than 48 hours.
Informed consent obtained from patient or legal guardian.
|
|
| ExclusionCriteria |
| Details |
ICU admission more than 48 hours at the time of screening.
Unable to assess for delirium (eg, coma or deep sedation; receiving neuromuscular blocking drugs) at the time of screening.
History of severe cognitive or neurodegenerative disease (eg, dementia, Parkinson’s disease) or severe structural brain injury (eg, traumatic brain injury, intracranial haemorrhage.
Severe hepatic or renal dysfunction.
Known allergy to melatonin.
Absolute contradiction to enteral nutrition (eg, gastrointestinal obstruction,perforation,recent gastrointestinal surgery,deemed strict nil by mouth,lack of enteral access).
Pregnant and lactating women.
Active seizures.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of delirium |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of Delirium,
Time to Onset of Delirium, Length of ICU Stay,
Sedation Requirements,
Sleep Quality,
ICU mortality |
14 Days |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
19/01/2026 |
| 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)
|
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
|
BACKGROUND OF PRESENT STUDY: Delirium is a common and serious syndrome pf acute brain dysfunction associated with negative outcomes.Melatonin may have a role in delirium prevention for critically ill adults based on data from non critically ill patient populations.Our objective was to the hypothesis that Melatonin given prophylactically may have a role in preventing delirium in adults who are critically ill. OBJECTIVE OF PROPOSED RESEARCH: To assess the effectiveness of Melatonin in preventing ICU delirium in critically ill patients. METHODOLOGY:A Prospective Observational Study Design will be employed,selecting patients who meet specified inclusion criteria.Participants will be randomly allotted to either Melatonin intervention group (Group-M) or a Control group (Group-C) receiving conventional therapy. The intervention involves giving Syrup Melatonin 3mg orally or via nasogastric tube at 9pm daily for 14 days.Outcomes assessed will include incidence and duration of Delirium. EXPECTED OUTCOME: As this is a prospective study, the outcome will be obtained only after the recording,compilation and analysis of data.However, as per previous studies, it is anticipated that Melatonin supplementation may reduce the incidence of Delirium in ICU patients by promoting sleep and stabilizing circadian rhythms, thus improving overall outcomes. |