| CTRI Number |
CTRI/2019/09/021460 [Registered on: 30/09/2019] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study done to assess the effects of Vitamin B1 - Vitamin C adjunct therapy in patients with (external forces) traumatic insult to brain. |
|
Scientific Title of Study
|
Thiamine - Ascorbic acid adjuvant therapy in Traumatic Brain Injury – A randomized, controlled, parallel-group study |
| Trial Acronym |
TAB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Garima Sinha |
| Designation |
Senior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh |
| Address |
Department of Anaesthesia, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9916441927 |
| Fax |
|
| Email |
garimasinha.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghanshyam Yadav |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh |
| Address |
Department of Anaesthesia, Institute of Medical Sciences, B.H.U.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838894169 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ghanshyam Yadav |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh |
| Address |
Department of Anaesthesia, Institute of Medical Sciences, B.H.U.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838894169 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [N/A] |
|
|
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 Garima Sinha |
Intensive Care Unit, Trauma Centre, Banaras Hindu University, Varanasi, Uttar Pradesh |
Departmnt of Anaesthesia, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
9916441927
garimasinha.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S06||Intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Thiamine & Ascorbic acid adjuvant therapy |
All patients with head injury admitted to the Trauma centre ICU with primary neurosurgical diagnosis shall be classified based on their Glasgow Coma Scores into into minor, moderate and severe head injuries. Patients meeting the inclusion & exclusion criteria will be randomly assigned into two groups of 80 each with the help of simple random sampling technique. Patients belonging to study group shall be given Injection Thiamine 200 mg BD intravenously and Injection Vitamin C 1.5 gm QID intravenously. The control group will not be given either Vitamin C or Thiamine. The Study drugs will be given for a period of 4 days. Days of ICU stay, serum Lactate trends, WBC counts, Neurological scoring trends via GCS & FOUR scoring, super-infection, number of ventilator days and 28-day mortality will be observed and recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (18 – 60 yrs) with an ASA physical status I and II of either sex
2. History of Traumatic Brain Injury
3. Patients getting admitted to the Trauma ICU with head injury, whether operated or not |
|
| ExclusionCriteria |
| Details |
1. Patients below 18yrs or above 60yrs
2. Pregnant women
3. Patients with G-6-PD deficiency
4. Patients with a history of nephrolithiasis/Gout/renal disorders/chronic renal failure
5. Immunocompromised patients (taking >10 mg of prednisone equivalent per day for at least 2 weeks, receiving cytotoxic therapy or diagnosed with an acquired immunodeficiency syndrome)
6. Chronic alcoholics/liver disease patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Days of ICU stay
Serum Lactate levels
WBC counts
Neurological scoring trends via GCS & FOUR scoring
Superinfection
Number of ventilator days |
15 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2019 |
| Date of Study Completion (India) |
31/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2021 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The knowledge of pathophysiology after Traumatic Brain Injury (TBI) has made us target the treatment towards limitation of the secondary injury (delayed non-mechanical damage) since the primary insult cannot be therapeutically limited/prevented. Thiamine and Ascorbate therapy has emerged as a promising neuroprotective intervention considering the underlying pathologic and inflammatory mechanisms of TBI. The therapy requires clinical pursuit with more extensive clinical research evidence. In this study, 160 TBI patients shall be recruited after they meet the pre-requisites for inclusion and exclusion. They shall be classified based on their baseline Glasgow Coma Scores and randomly assigned either the Study or the Control group. The study group patients will be administered study drugs. Further diagnostic workup and management of all the patients shall be undertaken as per the department protocols. Response to treatment will be recorded at pre-defined intervals, surrogated by the laid down outcome measures. Outcomes will be defined at the end of 28 days or discharge or death, whichever is earlier. |