Back to resultsEfficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy
Primary Purpose
Bell Palsy
Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Prednisolone
Cerebrolysin
Sponsored by
About this trial
This is an interventional treatment trial for Bell Palsy
Eligibility Criteria
Inclusion Criteria: unilateral acute facial palsy of no identifiable cause Exclusion Criteria: Recurrent facial Bell's palsy Pregnancy Diabetes Epilepsy Severe hypertension, Renal or hepatic disease, Gastric or duodenal ulcer presence of acute otitis media or ipsilateral chronic otitis Recent head injury, psychiatric disease If there is any contraindications for corticosteroids
Sites / Locations
- October 6 university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Prednisolone
Cerebrolysin
Prednisolone and Cerebrolysin
Arm Description
Outcomes
Primary Outcome Measures
change in scores of the house Brackman grading system HB
changes in scores of the Sunnybrook grading system.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05821075
Brief Title
Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy
Official Title
Comparative Study Between Prednisolone, Cerebrolysin in the Treatment of Bell's Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bell's palsy, a peripheral facial nerve paresis, is the most common disorder of the facial nerve and one of the most common mononeuropathies.
Many patients with Bell's palsy will develop some complications such as synkinesis, crocodile tears and 'sweating' of the ear while eating Commonly used medications to treat Bell's palsy is Corticosteroids Cerebrolysin stimulates the regeneration of the nervous tissue with protective action we aim to study the efficacy of cerebrolycin in Bell's palsy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisolone
Arm Type
Active Comparator
Arm Title
Cerebrolysin
Arm Type
Active Comparator
Arm Title
Prednisolone and Cerebrolysin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
prednisolone 60mg tablet once daily for 5 days then tapering dose
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin
Intervention Description
intramuscular Cerebrolysin 10 mg daily for 3 weeks
Primary Outcome Measure Information:
Title
change in scores of the house Brackman grading system HB
Time Frame
at baseline, after 1 week, after 3 week
Title
changes in scores of the Sunnybrook grading system.
Time Frame
at baseline, after 1 week, after 3 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
unilateral acute facial palsy of no identifiable cause
Exclusion Criteria:
Recurrent facial Bell's palsy
Pregnancy
Diabetes
Epilepsy
Severe hypertension,
Renal or hepatic disease,
Gastric or duodenal ulcer
presence of acute otitis media or ipsilateral chronic otitis
Recent head injury,
psychiatric disease
If there is any contraindications for corticosteroids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Engy Wahsh
Phone
01003095692
Email
engywahsh@o6u.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed rez
Phone
01006904056
Email
Abdelmaksodm.mousa@hotmail.com
Facility Information:
Facility Name
October 6 university hospital
City
Giza
ZIP/Postal Code
12573
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelmaksod Mohammed Mousa, MD
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy
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