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CTRI Number  CTRI/2024/02/063206 [Registered on: 27/02/2024] Trial Registered Prospectively
Last Modified On: 26/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Guillain-Barré Syndrome: Choosing the Best Treatment - Plasma Exchange vs. Immunoglobulin Therapy 
Scientific Title of Study   Comparing the Therapeutic Modalities of Guillain–Barré Syndrome: Therapeutic Plasma Exchange versus Intravenous Immunoglobulin 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nilasish Pani  
Designation  PG student 
Affiliation  SCB Medical College and Hospital 
Address  Department of Transfusion Medicine, SCB MCH, Mangalabag, Cuttack

Cuttack
ORISSA
753007
India 
Phone  8763181197  
Fax    
Email  paninilasish@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Smita Mahapatra 
Designation  Professor and HOD 
Affiliation  SCB Medical College and Hospital 
Address  Department of Transfusion Medicine, SCB MCH, Mangalabag, Cuttack

Cuttack
ORISSA
753007
India 
Phone  8763181197  
Fax    
Email  dr.smitamahapatra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nilasish Pani  
Designation  PG student 
Affiliation  SCB Medical College and Hospital 
Address  Department of Transfusion Medicine, SCB MCH, Mangalabag, Cuttack

Cuttack
ORISSA
753007
India 
Phone  8763181197  
Fax    
Email  paninilasish@gmail.com  
 
Source of Monetary or Material Support  
SCB Medical College and Hospital, Cuttack 
 
Primary Sponsor  
Name  SCB Medical College and Hospital 
Address  Mangalabag, Cuttack 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nilasish Pani  SCB Medical College and Hospital  Department of Transfusion Medicine, Department of Medicine, Department of Neurology, SCB Medical College and Hospital, Mangalabag, Cuttack
Cuttack
ORISSA 
8763181197

paninilasish@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, SCB Medical College and Hospital,Cuttack  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G610||Guillain-Barre syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INTRAVENOUS IMMUNOGLOBULIN  first line treatment for patients of Guillain Barre Syndrome frequency: 2 gm per kg given over 5 days total duration: 5 days 
Intervention  THERAPEUTIC PLASMA EXCHANGE  first line treatment for patients of Guillain Barre Syndrome frequency: 5 sessions over 10 days total duration: 10 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Clinically and electro physiologically diagnosed cases of GBS with

The cases will be age and sex matched

Both procedures are indicated 
 
ExclusionCriteria 
Details  1. Patients of GBS who have achieved plateau of GBS
2. Previous episodes of GBS
3. Pregnancy
4. Severe concurrent Medical illness like TB
5. Any one of these procedures contraindicated
6. Patients whose modality of treatment has been changed from IVIG to TPE or vice versa
7. Specific exclusions with atypical features such as-
a. Purely sensory symptoms
b. Cranial nerve palsies without significant limb weakness
c. Improvement of one or more disability grades before inclusion 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
A decrease in GBS Disability scale by 1 or more points at discharge as compared to the same at admission  Patient will be evaluated as per GBS disability score throughout the treatment period and up to 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
total cost of treatment in Indian Rupees   from the day of admission to the day of discharge 
 
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   Phase 4 
Date of First Enrollment (India)   08/03/2024 
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="0"
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–Barré syndrome (GBS) is the most common cause of acute flaccid paralysis worldwide, with an annual global incidence of approximately 1–2 per 100,000 person-year. Specific treatment of the patients comprises intravenous immunoglobulin (IVIG) or plasma exchange (PE). Majority of studies comparing either modalities of treatment has been conducted in developed countries with better Hospital infrastructure and mechanical ventilation facilities. Therefore it’s necessary to elicit the outcome of GBS in resource poor settings like ours. Moreover most of the studies comparing either modalities of therapy, have been done retrospectively. Further, studies evaluating functional neurological outcomes after IVIG or PE are lacking. Therefore with this study we aim to compare PE and IVIG as a first line treatment for patients with GBS in our setup in terms of neurological outcomes of the affected patients.

 

This is a randomized parallel group trial consisting of 45 patients in each arm selected by convenient sampling and randomized via computerized random number generator, where adult patients of either sex with clinical and electrophysiological diagnosis of GBS will be included. Patients with comorbidities, those with clinical plateau of disease and those where either of the therapeutic modalities are contraindicated, will be excluded from the study. Therapy with either IVIG or PE will be started after randomization and patient will be evaluated as per GBS disability score throughout the treatment period at day 0,7,14, 28 and at 6 months. A decrease in GBS Disability scale by 1 or more points at discharge as compared to the same at admission will be considered as the outcome measure.

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