| CTRI Number |
CTRI/2024/09/073973 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical profile of patients presenting with ascending weakness of both lower limbs followed by upper limbs.
A detailed study on Gullian Barre Syndrome |
|
Scientific Title of Study
|
Clinical Profile of Gullian Barre Syndrome in a rural hospital in Central 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 Mathaklala Aparna |
| Designation |
DM Student |
| Affiliation |
Jawaharlal Nehru medical college |
| Address |
Department of Neurosciences,
Acharya Vinoba Bhave Rural Hospital,
Sawangi,
Wardha
Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of higher Education and Research (DU), SAWANGI, (MEGHE), WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
7997996244 |
| Fax |
|
| Email |
dr.maparnarao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Harshal Rathod |
| Designation |
DM Neurology |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Neurosciences,
Acharya Vinoba Bhave Rural Hospital,
Sawangi,
Wardha
Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of higher Education and Research (DU), SAWANGI, (MEGHE), WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9764031941 |
| Fax |
|
| Email |
harshjan80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Mathakala Aparna |
| Designation |
DM Student |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Neurosciences,
Acharya Vinoba Bhave Rural Hospital,
Sawangi,
Wardha
Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of higher Education and Research (DU), SAWANGI, (MEGHE), WARDHA
Wardha
MAHARASHTRA
442001
India |
| Phone |
7997996244 |
| Fax |
|
| Email |
dr.maparnarao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of higher Education and Research (DU), Sawangi, (Meghe), Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
DR Mathakala Aparna |
| Address |
Department of neurosciences,
Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of higher Education and Research (DU), Sawangi, (Meghe), Wardha - 442001, Maharashtra, 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 Mathakala Aparna |
Acharya Vinoba Bhave Rural Hospital |
Department of Neurosciences,
Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of higher Education and Research (DU), Sawangi, (Meghe), Wardha
Wardha
MAHARASHTRA |
7997996244
dr.maparnarao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jawaharlal Nehru Medical College,Datta Meghe Institute of higher Education and Research (DU), Sawangi, (Meghe), Wardha, Maharastra-442001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G379||Demyelinating disease of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Confirmed Diagnosis: Patients with a confirmed diagnosis of GBS based on clinical
criteria, electrophysiological studies, and cerebrospinal fluid analysis.
2. Age Range: Include patients of age above 18 years
3. Patients presenting with Acute flaccid Paralysis with 28 days of illness.
4. Consent: Patients or their guardians must provide informed consent to participate in
the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with features of Hypokalemic periodic paralysis.
2. Patients with features of upper motor neuron signs and symptoms.
3. Patients admitted with history of exposure to toxins.
4. Patients with severe terminal illness.
5. Patients in whom the weakness progressed for more than 4 weeks.
6. Patients age less than 18 years of age
7.Patients with a chronic form of GBS, such as chronic inflammatory demyelinating
polyneuropathy (CIDP), to maintain focus on the acute presentation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prognosis of the disease will be studied based on the power improvement in all limbs. |
at every 2 weeks for 6 months power will be assessed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ICU requirement of the patient will be assessed for how many days. |
at 2 weeks, 4 weeks, 6 weeks. for every 2 weeks assesemenet will be done |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
24/09/2024 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.maparnarao@gmail.com].
- For how long will this data be available start date provided 20-12-2025 and end date provided 20-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In this thesis, focusing on the clinical profile of Guillain-Barré Syndrome (GBS), Prevalance of GBS and clinical outcomes can be known in a Rural Hospital in Central India. Response to Treatment: Evaluating improvement or deterioration following treatments such as intravenous immunoglobulin (IVIG) or plasmapheresis. Time to Peak Disability: Measures the time from symptom onset to the worst point of disability. Time to Recovery: Assesses the duration from peak disability to significant recovery milestones, such as when patient will be able to walk independently can be known. |