| CTRI Number |
CTRI/2020/07/026497 [Registered on: 10/07/2020] Trial Registered Prospectively |
| Last Modified On: |
09/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the varied presentations of Guillain Barre Syndrome |
|
Scientific Title of Study
|
Clinical and Electrophysiological Profile of Guillain Barre Syndrome With a Comparative Study on utility of Asbury versus Brighton Criteria in diagnosis of Guillain Barre Syndrome: in a tertiary hospital in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NAMAN MUKHI |
| Designation |
DM NEUROLOGY RESIDENT |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION (UNIVERSITY) |
| Address |
DEPARTMENT OF NEUROLOGY, KASTURBA MEDICAL COLLEGE, MAINPAL
Udupi
KARNATAKA
576104
India |
| Phone |
09986206469 |
| Fax |
|
| Email |
dr.namanmukhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
APARNA PAI |
| Designation |
PROFESSOR AND HEAD, DEPARTMENT OF NEUROLOGY, KMC MANIPAL |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION (UNIVERSITY) |
| Address |
DEPARTMENT OF NEUROLOGY, KASTURBA MEDICAL COLLEGE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9880182224 |
| Fax |
|
| Email |
aprpai@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
NAMAN MUKHI |
| Designation |
DM NEUROLOGY RESIDENT |
| Affiliation |
MANIPAL ACADEMY OF HIGHER EDUCATION (UNIVERSITY) |
| Address |
DEPARTMENT OF NEUROLOGY, KASTURBA MEDICAL COLLEGE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
09986206469 |
| Fax |
|
| Email |
dr.namanmukhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE, MANIPAL |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| NAMAN MUKHI |
KASTURBA HOSPITAL, KASTURBA MEDICAL COLLEGE, MANIPAL |
ROOM NUMBER 11, NEUROLOGY OPD, NEUROLOGY WARD,
Udupi
KARNATAKA |
09986206469
dr.namanmukhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients Fulfilling the diagnostic criteria for Guillain Barre Syndrome as per developed by Asbury and Cornblath (1990) criteria OR BRIGHTON CRITERIA
2)Presentation within 2 weeks of symptom onset
|
|
| ExclusionCriteria |
| Details |
1) Age less than 18 years
2) Not consenting for study
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Ability of ASBURY AND BRIGHTON CRITERIA IN ESTABLISHING ACCURATE DIAGNOSIS IN SUSPECTED CASES OF GUILLAIN BARRE SYNDROME IN A TERTIARY HEALTH CARE SETTING |
Ability of ASBURY AND BRIGHTON CRITERIA IN ESTABLISHING ACCURATE DIAGNOSIS IN SUSPECTED CASES OF GUILLAIN BARRE SYNDROME ON ADMISSION TO HOSPITAL AND DURING THE COURSE OF STAY IN HOSPITAL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical and electrophysiological profile of various guillaine barre syndrome patients |
At presentation and during the course of hospital stay |
|
|
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)
|
15/07/2020 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Gullain Barre syndrome(GBS) is a devastating illness causing acute flaccid paralysis . The pathophysiology and treatment responses for GBS have been primarily studied in western populations. Our tertiary centre has been treating GBS for a long time but clinical presentations, immunological profile and treatment outcomes are possibly different from earlier studies in other populations. Also there is need to identify these patients of varied presentation of GBS at the earliest as earlier standard treatment initiation will affect the course of illness. Hence to study the varied presentations and outcomes this study has been proposed. We also propose to compare the usefulness of Asbury criteria with the newly introduced brighton criteria to compare their usefulness in early and accurate diagnosis of GBS as these criteria have been validated in the western population but not in the Indian population. |