| CTRI Number |
CTRI/2015/10/006294 [Registered on: 21/10/2015] Trial Registered Prospectively |
| Last Modified On: |
03/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Explratory Study |
| Study Design |
Other |
|
Public Title of Study
|
To determine the pattern of alcohol use and associated high risk behavior among alcohol dependent individuals |
|
Scientific Title of Study
|
A study to assess the pattern of alcohol use and associated high risk behaviors among alcohol dependent individuals in a selected de-addiction centre at mangalore |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Minnu Joy |
| Designation |
PG Student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Pullolickal house
Chunda po
Vayalai
Kannur
Pullolickal house
Chunda po
Vayalai
Kannur
Kannur
KERALA
670511
India |
| Phone |
7676636824 |
| Fax |
|
| Email |
minnujoy696@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Rajeeve Mathew |
| Designation |
Assisstant Professor |
| Affiliation |
Father Muller Charitable Institutions |
| Address |
Father Muller College Of Nursing
Kankanady
Mangalore
Father Muller College Of Nursing
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9986969037 |
| Fax |
|
| Email |
rajivmathew55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leena KC |
| Designation |
Professor |
| Affiliation |
Father Muller Charitable Institutions |
| Address |
Father Muller College Of Nursing
Kankanady
Mangalore
Father Muller College Of Nursing
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9448059698 |
| Fax |
|
| Email |
leenakchacko@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital
FMCI
Kankanady
Mangalore
575002 |
|
|
Primary Sponsor
|
| Name |
Ms Minnu Joy |
| Address |
Pullolickal house
Chunda po
Vayalai
Kannur |
| Type of Sponsor |
Other [self funded ] |
|
|
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 |
| ProfChanu Bhattacharya |
Father Muller Medical College Hospital |
Meeting Hall
Deaddiction Centre
Father Muller Campus
FMCI
Mnagalore
575002
Dakshina Kannada
KARNATAKA |
9886635139
08242238324
canboy142002@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Alcohol Dependent Individuals after 72hrs of detoxification, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who are able to communicate in english ,kannada or malayalam
Individuals after 72 hours of detoxification treatment
Individuals who score 25 or above in the mini mental status examination . |
|
| ExclusionCriteria |
| Details |
Individuals who are diagnosed with psychiatric disorders
Individuals with multiple substance abuse
Individual abuse a single other than alcohol |
|
|
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 |
| To aware about risk behaviour and pattern of alcohol use |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce risk behaviours |
1year |
|
|
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)
|
07/12/2015 |
| 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="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
study to assess the pattern of alcohol use and associated high risk pattern. H1:There will be significant correlation between pattern of alcohol use and associated high risk behaviors |