| CTRI Number |
CTRI/2023/11/059392 [Registered on: 01/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on brain and nerve related disorders and their risk factors in adult population of Udupi Taluk, Karnataka,India |
|
Scientific Title of Study
|
Neurological disorders and their risk factors among adult population in Udupi taluk, Karnataka, India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jeleeta John K |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College,MAHE,Manipal |
| Address |
Department of Community Medicine
Kasturba Medical College
MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7012269276 |
| Fax |
|
| Email |
jeleeta.kmcmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Arvind Prabhu |
| Designation |
Associate Professor,Guide |
| Affiliation |
Kasturba Medical College,MAHE,Manipal |
| Address |
Department of Community Medicine
Kasturba Medical College
MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9916281108 |
| Fax |
|
| Email |
dv.pai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Arvind Prabhu |
| Designation |
Associate Professor,Guide |
| Affiliation |
Kasturba Medical College,MAHE,Manipal |
| Address |
Department of Community Medicine
Kasturba Medical College
MAHE,Manipal
KARNATAKA
576104
India |
| Phone |
9916281108 |
| Fax |
|
| Email |
dv.pai@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
Kasturba Medical College
MAHE,Manipal
Near Tiger Circle,Manipal,Udupi
Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Dr Jeleeta John K |
| Address |
Department of Community Medicine
Kasturba Medical College
MAHE,Manipal-576104 |
| 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 |
| DrJeleeta John K |
Kasturba Medical College,MAHE,Manipal |
Department of Community Medicine
Room no:1
Near Biochemistry Block
Udupi
KARNATAKA |
7012269276
jeleeta.kmcmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, (2) ICD-10 Condition: G439||Migraine, unspecified, (3) ICD-10 Condition: G819||Hemiplegia, unspecified, (4) ICD-10 Condition: F039||Unspecified dementia, (5) ICD-10 Condition: S062||Diffuse traumatic brain injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Persons aged 18 years and above
2)Those who are residing in the field practise area,Department of Community Medicine,KMC Manipal for more than 6 months
3)Those who are willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
1)Pediatric neurological disorders like cerebral palsy,pediatric age group related inborn errors of metabolism and proven genetic disease.
2)Acute Communicable neurological disorders like meningitis/meningoencephalitis and brain infections.
3)Other neurological disorders like Motor neuron disease, Neuromuscular disorder like Myasthenia gravis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Neurological disorders |
1 year 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of association of various risk factors with neurological disorders |
1 year 4 months |
|
|
Target Sample Size
|
Total Sample Size="2633"
Sample Size from India="2633"
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)
|
01/12/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective study-cross sectional study to estimate the prevalence of neurological disorders among adults residing in the field practise area of Department of Community Medicine, KMC, MAHE, Manipal and to study the association of various risk factors on neurological disorders among these adults. Sample size is estimated to be 2633.Study is conducted for a period of 1year and 4 months. |