| CTRI Number |
CTRI/2014/01/004321 [Registered on: 16/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
23/12/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of disorders of higher mental functions in the spouses of patients who are addicted to alcohol |
|
Scientific Title of Study
|
A study on the cognitive dysfunctions in spouses of patients with alcohol dependence syndrome
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rinet Sonia Dsouza |
| Designation |
Post graduate resident |
| Affiliation |
Father Muller Medical College |
| Address |
Department of psychiatry,
Father muller medical college
Father muller Road, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8971836564 |
| Fax |
|
| Email |
dr.sonia@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JohnPMathai |
| Designation |
Professor and HOD of Psychiatry |
| Affiliation |
Father Muller Medical College |
| Address |
Department of psychiatry,
Father muller medical college
Father muller Road, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
pjohnmathai@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinet Sonia Dsouza |
| Designation |
Post graduate resident |
| Affiliation |
Father Muller Medical College |
| Address |
Department of psychiatry,
Father muller medical college
Father muller Road, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8971836564 |
| Fax |
|
| Email |
dr.sonia@ymail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rinet Sonia Dsouza |
| Address |
Post graduate resident, Department of psychiatry, Father muller medical college, Father muller Road, Kankanady Mangalore-575002 Karnataka INDIA |
| Type of Sponsor |
Other [Self] |
|
|
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 Rinet Sonia Dsouza |
Deaddiction centre and Psychiatry ward of Father Muller Medical College Hospital |
Father Muller road Kankanady Mangalore- 575002
Dakshina Kannada
KARNATAKA |
8971836564
dr.sonia@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy spouses |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria for the Experimental Group :
1.Spouses of patents with alcohol dependence
syndrome as per ICD-10 criteria.
2.Spouses of age between 18-60 years.
3.Persons who give consent for the study
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria for the Experimental Group :
1.Persons with any chronic lifestyle modifying
illness like Diabetes Mellitus, Hypertension.
2.Persons with any history of substance abuse.
3.Persons with any psychiatric disorders.
4.Persons with any major medical illness.
5.Persons suffering from neurodegenerative
diseases and with family history of
neurodegenerative diseases in first degree
relatives.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A total 30 number of spouses selected will be evaluated based on following scales to estimate the cognitive functions:-
a) Standardized Mini Mental
State Examination (SMMSE)
b) Trail Making Test B
c) Digit Symbol Substitution
Test |
From October 2013 to January 2014 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of alcohol dependence is done as per ICD-10 criteria and socio-economic status is assessed as per Kuppuswamy scale |
1 time point |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/10/2013 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No Details Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational study to assess the cognitive dysfunctions in souses of patients with alcohol dependence syndrome. Data will be collected from the spouses of the patients with alcohol dependence syndrome admitted in the deaddiction centre and the psychiatry ward of Father Muller medical college hospital. Assessment of alcohol dependence will be done as per ICD-10 criteria. Socio-economic status will be assessed as per Kuppuswamy Scale Samples will be evaluated using following scales to estimate the cognitive functions:- a) Standardized Mini Mental State Examination (SMMSE) b) Trail Making Test B c) Digit Symbol Substitution Test |