| CTRI Number |
CTRI/2025/12/099193 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Thiamine on cognition in people with alcohol depedence |
|
Scientific Title of Study
|
Efficacy of high dose Thiamine on cognitive function in patients with alcohol depedence syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Cyril Joy V Merina |
| Designation |
MD Psychiatry Junior Resident |
| Affiliation |
Central Institute of Psychiatry, Ranchi, Kanke, Ranchi, Jharkhand |
| Address |
Research Laboratory, Department of Psychiatry, Central Institute of Psychiatry, Ranchi, Kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
9447176240 |
| Fax |
|
| Email |
cyriljoym007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunilkumar R Suryavanshi |
| Designation |
Professor, Department of Psychiatry |
| Affiliation |
Central Institute of Psychiatry, Ranchi, Kanke, Ranchi, Jharkhand |
| Address |
Consultant Room, Administrative Office, Department of Psychiatry, Central Institute of Psychiatry, Ranchi, Kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
8007774822 |
| Fax |
|
| Email |
sunilsuryavanshi5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sunilkumar R Suryavanshi |
| Designation |
Professor, Department of Psychiatry |
| Affiliation |
Central Institute of Psychiatry, Ranchi, Kanke, Ranchi, Jharkhand |
| Address |
Consultant Room, Administrative Office, Department of Psychiatry, Central Institute of Psychiatry, Ranchi, Kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
8007774822 |
| Fax |
|
| Email |
sunilsuryavanshi5@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry, Ranchi |
| Address |
Central Institute of Psychiatry, Ranchi, Kanke, Ranchi 834006 , Jharkhand |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Cyril Joy V Merina |
Central Institute of Psychiatry |
Research Laboratory,Department of Psychiatry, Central Institute of Psychiatry, Ranchi, Kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND |
9447176240
cyriljoym007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, CIP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
For the control group, treatment as usual that is Injection thiamine will be given as per the dosage of 300mg thrice daily at 8am, 12pm and 4pm respectively for first five days of the study. Further, Thiamine will be continued as per the dosage of 100mg 3 tablets thrice daily at 8am, 12pm and 4pm for the remaining 23 days of the study. |
| Intervention |
Thiamine |
For the intervention group,
Injection thiamine will be given as per the dosage of 1000mg twice daily at 8am and 4pm respectively for first five days of the study.
Thiamine will then be continued as per the dosage of 500mg, 2 tablets twice daily at 8am and 4pm for the remaining 23 days of the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Alcohol Dependence Syndrome as per International Classification of Disease – 10th revision
Patients with Severity of Alcohol Dependence Questionnaire (SADQ) greater than 16
Patients with Clinical Institute Withdrawal Assessment for Alcohol (revised version) (CIWA-Ar) less than or equal to 7
Patients will be screened for cognitive deficit with Montreal Cognitive Assessment Test (MoCA), with score between 18 to 25
Patients with Beck Depression Inventory score less than or equal to 9
Patient who is ready to give informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with history of significant head injury.
Patients having any other co-morbid substance dependence.
Patients with clinically diagnosed intellectual disability, autism spectrum disorder.
Patients having condition accompanied by impaired cognitive functioning or specific psychiatric conditions
Patients with any medical or surgical illness that interferes with the absorption and metabolism of thiamine
Patients on any drugs that interferes with the absorption and metabolism of thiamine
Patients who have received any form of thiamine within the last 4 weeks |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant effect of high dose thiamine (i.e.2000mg) on blood levels of thiamine pyrophosphate and cognitive function. |
2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Significant correlation exists between baseline level of thiamine pyrophosphate in blood & cognitive function of experimental group & treatment as usual group.
significant correlation between thiamine pyrophosphate & cognitive function in both groups at 2 weeks & 4 weeks. |
Baseline, 2 weeks & 4 weeks |
|
|
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)
|
01/01/2026 |
| 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="0"
Months="2"
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
|
This prospective randomized control study investigates the efficacy of high-dose thiamine on cognitive function in patients with Alcohol Dependence Syndrome. Conducted at the Central Institute of Psychiatry, the protocol involves 60 patients (aged 18-50) with mild cognitive impairment, randomized into an experimental group (n=30) and a treatment-as-usual group (n=30) The experimental group receives 1000mg of thiamine twice daily (IV) for five days, followed by 500mg orally twice daily for 23 days, whereas the control group receives standard lower doses (300mg IV thrice daily, then 100mg oral thrice daily). Key assessment tools include the Montreal Cognitive Assessment (MoCA), Wisconsin Card Sorting Test (WCST), and blood thiamine pyrophosphate (TPP) levels. Evaluations are conducted at baseline, two weeks, and four weeks to statistically analyze the correlation between thiamine levels and cognitive recovery
|