Back to resultsEarly and Late Prognosis in Patients With Guillain-Barre Syndrome
Primary Purpose
Guillain-Barre Syndrome
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Intravenous Immunoglobulins, Human
Methylprednisolone 500 MG Injection
Sponsored by
About this trial
This is an interventional prevention trial for Guillain-Barre Syndrome focused on measuring Guillain-barre syndrome, prognosis
Eligibility Criteria
Inclusion Criteria: patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome. Exclusion Criteria: nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome
Sites / Locations
- First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
Experimental
Arm Label
immunoglobulin group
methylprednisolone group
control group
mixed group
Arm Description
This group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
This group of patients was treated with methylprednisolone 500 MG Injection
This group of patients was treated without immunoglobulin or hormone
This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.
Outcomes
Primary Outcome Measures
the severity of Guillain-barre syndrome
The Guillain-barre syndrome disability score is a wide scale for the severity of Guillain-barre syndrome (0, optimal health; 1, minor symptoms, able to run; 2, able to walk unaided 10 m, unable to run; 3, able to walk 10 m across an open space with help; 4 bedridden or wheelchair users; 5, require assisted ventilation; 6, dead).The higher the score, the worse the prognosis.
Secondary Outcome Measures
Full Information
NCT ID
NCT06041451
First Posted
December 27, 2022
Last Updated
September 11, 2023
Sponsor
First Affiliated Hospital of Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT06041451
Brief Title
Early and Late Prognosis in Patients With Guillain-Barre Syndrome
Official Title
Early and Late Prognosis in Patients With Guillain-Barre Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2013 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.
Detailed Description
This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guillain-Barre Syndrome
Keywords
Guillain-barre syndrome, prognosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
immunoglobulin group
Arm Type
Experimental
Arm Description
This group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
Arm Title
methylprednisolone group
Arm Type
Experimental
Arm Description
This group of patients was treated with methylprednisolone 500 MG Injection
Arm Title
control group
Arm Type
No Intervention
Arm Description
This group of patients was treated without immunoglobulin or hormone
Arm Title
mixed group
Arm Type
Experimental
Arm Description
This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.
Intervention Type
Drug
Intervention Name(s)
Intravenous Immunoglobulins, Human
Intervention Description
patients were treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone 500 MG Injection
Intervention Description
patients were treated with methylprednisolone
Primary Outcome Measure Information:
Title
the severity of Guillain-barre syndrome
Description
The Guillain-barre syndrome disability score is a wide scale for the severity of Guillain-barre syndrome (0, optimal health; 1, minor symptoms, able to run; 2, able to walk unaided 10 m, unable to run; 3, able to walk 10 m across an open space with help; 4 bedridden or wheelchair users; 5, require assisted ventilation; 6, dead).The higher the score, the worse the prognosis.
Time Frame
baseline, at 1 week, at 26 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome.
Exclusion Criteria:
nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binbin Deng
Phone
dbinbin@aliyun.com
Facility Information:
Facility Name
First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binbin Deng, Doctor
Phone
+8613695720610
Email
dbinbin@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
Early and Late Prognosis in Patients With Guillain-Barre Syndrome
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