| CTRI Number |
CTRI/2024/04/065303 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding clinical aspects of Guillain Barre Syndrome |
|
Scientific Title of Study
|
Study of Clinical profile, Prognostic factors, Treatment and Outcome in Guillain Barre Syndrome patients |
| 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 Rahul Kurade |
| Designation |
Post Graduate 2nd year resident |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
Opd no.62, Medicine department, Sir Takhtasinhji Hospital Campus, Bhavnagar-364001
Sir T Hospital, Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
8160550302 |
| Fax |
02782422011 |
| Email |
rahulsvk21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ila N Hadiyel |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
Department of Medicine, Medical College and Sir T hospital, Bhavnagar, Gujarat, India
Sir T Hospital, Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825315890 |
| Fax |
02782422011 |
| Email |
ilahadiyel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Kurade |
| Designation |
Post Graduate 2nd year resident |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
Opd no.62, Medicine department, Sir Takhtasinhji Hospital Campus, Bhavnagar-364001
Sir T Hospital, Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
8160550302 |
| Fax |
02782422011 |
| Email |
rahulsvk21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Sir Takhtsinhji General Hospital, Bhavnagar, India Pincode:364001 |
|
|
Primary Sponsor
|
| Name |
Dr Rahul Kurade |
| Address |
OPD no.62, Department of Medicine
Sir Takhtsinhji General Hospital,
Bhavnagar- 364001 (Gujarat)
|
| 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 Rahul Kurade |
Sir Takhtsinhji General Hospital |
critical care unit, general medicine ward, Department of General Medicine
Bhavnagar
GUJARAT |
8160550302
02782422011
rahulsvk21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Government Medical College,Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Guillain Barre Syndrome clinically in Sir T hospital aged ≥ 13 years in a period of 8 months after getting permission from ethics committee, Bhavnagar |
|
| ExclusionCriteria |
| Details |
1.HIV positive patients
2.Patients having electrolyte abnormality like persistent Hypokalemia
3.Transverse myelitis
4.Myasthenia Gravis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess clinical profile, prognostic factors, treatment and outcome in patients of Guillain Barre Syndrome
|
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of demographic details of disease.
2.To assess factors influencing clinical outcome of the disease.
3.To assess disease progression and prognosis in Guillain Barre syndrome patients.
|
8 months |
|
|
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)
|
01/05/2024 |
| 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="10"
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
|
Guillain Barre syndrome is an acute, frequently severe and fulminant disease requiring early diagnosis and prompt treatment. Understanding demographic details of the disease, its clinical course and outcome will aid in better management of the disease. This study is a Prospective Observational Study used to assess clinical profile, prognostic factors, treatment and outcome in patients with Guillain Barre Syndrome |