| CTRI Number |
CTRI/2021/12/039034 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
27/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of cognitive functions in patients with alcohol-dependence |
|
Scientific Title of Study
|
Assessment of cognitive functions in patients with alcohol-use disorder: Psycho Biochemical Evidences |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pankhita Ghai |
| Designation |
MBBS 2 Prof All India Institute of Medical Sciences Bathinda |
| Affiliation |
MBBS 2 Prof AIIMS BATHINDA |
| Address |
Department of Physiology
AIIMS Bathinda
Department of Physiology
AIIMS, Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9910110226 |
| Fax |
|
| Email |
pankhitaghai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipti Magan |
| Designation |
Assistant Professor All India Institute of Medical Sciences, Bathinda |
| Affiliation |
Assistant Professor AIIMS BATHINDA |
| Address |
Department of Physiology
AIIMS Bathinda
Department of Physiology
AIIMS Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
9910110226 |
| Fax |
|
| Email |
diptimagan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipti Magan |
| Designation |
Assistant Professor All India Institute of Medical Sciences Bathinda |
| Affiliation |
Assistant Professor AIIMS BATHINDA |
| Address |
Department of Physiology
AIIMS, Bathinda
Bathinda
PUNJAB
151001
India |
| Phone |
8847488733 |
| Fax |
|
| Email |
diptimagan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research Delhi |
| Address |
STS projects ICMR New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS BATHINDA |
DEPT OF PHYSIOLOGY AIIMS BATHINDA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dipti Magan |
All India Institute of Medical Sciences |
Department of Physiology
Bathinda
PUNJAB |
9910110226
diptimagan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMSETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
36.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Patients with alcohol dependence will be recruited from the OPD of the Department of Psychiatry, AIIMS, Bathinda.
Gender: male.
Age group 36 to 55 years.
Patients who have undergone alcohol use disorder identification test (AUDIT) criteria for the diagnosis of alcohol dependence |
|
| ExclusionCriteria |
| Details |
Patients with serious medical conditions, seriously sick, non-ambulatory, and non-cooperative patients.
Patient of significant liver disease (cirrhosis of liver).
History of drug dependence other than nicotine or caffeine.
Clinical evidence of Wernicke-Korsakoff syndrome.
Significant history of head trauma or brain surgery.
Patient with organic brain syndrome, psychotic disorder, major depressive disorder, and bipolar disorder.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It has been expected that relative to healthy controls, alcohol dependence patients may have poor cognitive scores evaluated by cognitive function tests ie MMSE and MoCA scores (as a primary outcome)
Also reducing the rate of cognitive decline assessed by blood levels of thiamine (as a secondary outcome) among Indian population with alcohol dependence patients. |
all parameters will be recorded at single time point when they will come to Psychiatric OPD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It has been expected that relative to healthy controls, alcohol dependence patients may have poor cognitive scores evaluated by cognitive function tests ie MMSE and MoCA scores (as a primary outcome)
Also reducing the rate of cognitive decline assessed by blood levels of thiamine (as a secondary outcome) among Indian population with alcohol dependence patients. |
two months |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
31/12/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
will be carried out after the completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction Alcohol consumption is associated with poor cognitive performance particularly executive functions, visuospatial skills, and episodic and working memory, though understanding the association has proved difficult. This variation is due to the methodological limitations in terms of study design ie population selection, age criteria, and a variety of neuropsychological tests measured. Also, little is known about the biological basis of these differences and the prognostic predictors for alcohol consumption. Further, the assessment of how rapidly cognitive impairment is progressing has important clinical implications, since the rate of disease progression may be the most important factor in determining prognosis. A biological marker for rapid cognitive decline would be of importance because at-risk patients can be targeted early for non-pharmacological, medical, and psychosocial interventions to slow deterioration. Thiamine, also known as vitamin B1, exerts neuroprotective effects by maintaining blood-brain barrier integrity, and is particularly, studied as a biological marker for cognitive decline. LACUNAE To date, no published literature is available to show the association of alcohol intake and rate of cognitive decline in alcohol-dependent patients among the Indian middle-aged population by evaluating mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), and a specific cognitive biomarker i.e., blood levels of thiamine (vitamin B1). Aim and Objectives AIM The present study was designed to understand the effect of harmful alcohol use on neuro-cognitive functions among the middle-aged (36-55years) Indian population. Objectives Primary Objective a. To assess the cognitive functions in middle-aged (36-55years) alcohol-dependent patients: · by evaluating mini-mental state examination (MMSE) and Montreal cognitive assessment (MoCA). · by evaluating the blood levels of cognitive biomarker i.e., plasma Thiamine (vitamin B1). Secondary Objective · To compare the above objectives with age and sex-matched healthy controls. |