| CTRI Number |
CTRI/2026/01/102466 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of citicoline and cerebrolysin in the management of severe traumatic brain injury a prospective randomized study. |
|
Scientific Title of Study
|
Role of Citicoline and Cerebrolysin combination in the management of severe traumatic brain injury: A Prospective Randomized 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 |
OBILI Manoj |
| Designation |
Junior resident 3rd year |
| Affiliation |
King Georges Medical University, Lucknow |
| Address |
Department of Anaesthesiology King Georges Medical University
Shah Mina Rd Chowk
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8919942528 |
| Fax |
|
| Email |
manojobili@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipin Kumar Singh |
| Designation |
Additional professor |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Anaesthesiology King Georges Medical University Lucknow Uttar Pradesh India
Shah Mina Road
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
6387908355 |
| Fax |
|
| Email |
vipintheazad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
OBILI Manoj |
| Designation |
Junior resident 3rd year |
| Affiliation |
King Georges Medical University, Lucknow |
| Address |
Department of Anaesthesiology King Georges Medical University
Shah Mina Rd Chowk
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8919942528 |
| Fax |
|
| Email |
manojobili@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded academic postgraduate dissertation study |
|
|
Primary Sponsor
|
| Name |
King Georges Medical University, Lucknow |
| Address |
Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003. |
| 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 |
| Dr Obili Manoj |
King Georges Medical University Lucknow |
Department of Anaesthesiology and Intensive Care Shah Mina Road Lucknow Uttar Pradesh India
Lucknow
UTTAR PRADESH |
8919942528
manojobili@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, King Georges Medical University U.P., Lucknow. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Citicoline and Injection Cerebrolysin |
Injection citicoline three grams intravenous once daily for fourteen days and injection cerebrolysin thirty milliliters intravenous once daily for fourteen days in addition to standard intensive care management. |
| Comparator Agent |
Normal saline intravenous infusion once daily for fourteen days in addition to standard intensive care management. |
Normal saline intravenous infusion once daily for fourteen days in addition to standard intensive care management. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 to 65 years with severe traumatic brain injury defined as Glasgow Coma Scale less than or equal to 8, admitted within 24 hours of injury, with CT scan evidence of traumatic brain injury, requiring intensive care management. |
|
| ExclusionCriteria |
| Details |
Postoperative TBI; NCCT evidence of midline shift or herniation; pre-existing renal/hepatic failure; pregnancy; known hypersensitivity to Citicoline or Cerebrolysin. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Serum Neuron-Specific Enolase (NSE) levels |
Baseline (Day 0), Day 7, and Day 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Glasgow Coma Scale (GCS) score |
Daily from Admission to Day 14. |
| Functional outcome via Glasgow Outcome Scale (GOS). |
At discharge and 3-month follow-up |
| Total Length of Hospital Stay and 14-day Mortality. |
During hospital stay. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2026 |
| 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 Yet Recruiting |
| 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
|
This is a prospective randomized study designed to evaluate the role of citicoline and cerebrolysin in patients with severe traumatic brain injury. Adult patients aged 18 to 65 years with severe traumatic brain injury will be randomized into two groups. One group will receive citicoline and cerebrolysin in addition to standard intensive care management while the control group will receive standard intensive care management. Neurological outcome will be assessed using Glasgow Coma Scale and Glasgow Outcome Scale during hospital stay. The study aims to compare neurological recovery and clinical outcomes between the two groups. |