| CTRI Number |
CTRI/2021/08/035400 [Registered on: 04/08/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Among the patients with alcohol use disorder, what is the frequency and level of cognitive impairment? |
|
Scientific Title of Study
|
proportion of Neurocognitive Impairment in Patients of Alcohol use disorder attending Sir T general hospital, Bhavnagar: A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suvidha Garg |
| Designation |
1st Year Resident |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
| Address |
DEPARTMENT OF PSYCHIATRY, SIR T GENERAL HOSPITAL & GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR
Bhavnagar
GUJARAT
364001
India |
| Phone |
7589159467 |
| Fax |
|
| Email |
suvidhagarg139@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHOK U VALA |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OF PSYCHIATRY |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
| Address |
DEPARTMENT OF PSYCHIATRY, SIR T GENERAL HOSPITAL & GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427774959 |
| Fax |
|
| Email |
drvala175@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUVIDHA GARG |
| Designation |
1ST YEAR RESIDENT, MD PSYCHIATRY |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
| Address |
DEPARTMENT OF PSYCHIATRY, SIR T GENERAL HOSPITAL & GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR
Bhavnagar
GUJARAT
364001
India |
| Phone |
7589159467 |
| Fax |
|
| Email |
suvidhagarg139@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT MEDICAL COLLEGE SIR T GENERAL HOSPITAL BHAVNAGAR |
| Address |
GOVERNMENT MEDICAL COLLEGE & SIR T GENERAL HOSPITAL, BHAVNAGAR 364001 |
| 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 SUVIDHA GARG |
SIR T GENERAL HOSPITAL, BHAVANAGAR |
SEMINAR ROOM, DEPARTMENT OF PSYCHIATRY, GOVERNMENT MEDICAL COLLEGE & SIR T GENERAL HOSPITAL, BHAVNAGAR
Bhavnagar
GUJARAT |
7589159467
suvidhagarg139@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMITTEE GMC BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1.Patients diagnosed with alcohol use disorder as per DSM-V criteria.
2. Patients that are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Age group >60yrs.
2. Patients in intoxicated state, withdrawal, delirium.
3. Patients not willing to give consent.
4. Patients having any neurological illness.
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| PROPORTION OF NEUROCOGNITIVE IMPAIRMENT IN PATIENTS WITH ALCOHO USE DISORDER |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE THE ASSOCIATION OF NEUROCOGNITIVE IMPAIRMENT WITH ALCOHOL DEPENDENCE AND QUALITY OF LIFE |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
05/08/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
after taking approval from ethics comittee, study will be initiated, patients fulfilling the inclusion criteria will be taken into study and interview will be taken as per 1. severity of alcohol dependence questionnaire, 2. st. louis university mental status test 3. WHO quality of life brief scale |