| CTRI Number |
CTRI/2013/08/003903 [Registered on: 19/08/2013] Trial Registered Retrospectively |
| Last Modified On: |
16/08/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of disorders of higher mental functions in chronic smokers |
|
Scientific Title of Study
|
A study on the cognitive dysfunctions in chronic smokers |
| 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 |
|
| 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 |
Room No. 36,Psychiatry outpatient department 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 |
| Patients |
Chronic Smoking, |
|
|
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.Chronic smokers- who smoke more than one to two cigarettes per day at least for 6 consecutive months.
2.Persons with age between 18-60 years.
3.Persons without any chronic lifestyle modifying illness like Diabetes Mellitus, Hypertension etc.
4.Persons without previously diagnosed psychiatric disorders.
5.Persons not suffering from neurodegenerative diseases and without family history of neurodegenerative diseases in first degree relatives.
6.Persons who give consent for the study.
Inclusion Criteria for the Control Group :
1.Persons who have never smoked.
2.Persons with age between 18-60 years.
3.Persons without any chronic lifestyle modifying illness like Diabetes Mellitus, Hypertension etc.
4.Persons without previously diagnosed psychiatric disorders.
5.Persons not suffering from neurodegenerative diseases and without family history of neurodegenerative diseases in first degree relatives.
6.Persons who give consent for the study.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria for the Experimental Group :
1.Persons who smoke other than cigarette namely marijuana, heroin etc.
Exclusion Criteria for the Control Group :
1.Persons who have smoked before
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A total 60 number of patients (30 cases and 30 controls)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
d) Cognitive Abilities Screening Instrument (CASI)
|
From December 2012 to January 2014 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of nicotine dependence is done as per Fagerstrom scale Score and socio-economic status is assessed as per A.K.Sharma Scale
|
1 time point |
|
|
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)
|
25/10/2012 |
| 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="2"
Months="0"
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 a case control study to compare the cognitive dysfunctions in chronic smokers with cognitive functions of those who have never smoked. data will be collected from the patients or attendees of the patients attending Father Muller medical college hospital outpatient clinic. Assessment of nicotine dependence will be done as per Fagerstrom scale Score. Socio-economic status will be assessed as per A.K.Sharma Scale Patients 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 d) Cognitive Abilities Screening Instrument (CASI) |