Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy
Comparative Study Between Prednisolone, Cerebrolysin in the Treatment of Bell's Palsy
1 other identifier
interventional
90
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedStudy Start
First participant enrolled
August 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedJuly 31, 2025
July 1, 2025
2.4 years
April 7, 2023
July 28, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
change in scores of the house Brackman grading system HB
at baseline, after 1 week, after 3 week
changes in scores of the Sunnybrook grading system.
at baseline, after 1 week, after 3 week
Study Arms (3)
Prednisolone
ACTIVE COMPARATORCerebrolysin
ACTIVE COMPARATORPrednisolone and Cerebrolysin
ACTIVE COMPARATORInterventions
prednisolone 60mg tablet once daily for 5 days then tapering dose
intramuscular Cerebrolysin 10 mg daily for 3 weeks
Eligibility Criteria
You may qualify if:
- unilateral acute facial palsy of no identifiable cause
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
October 6 university hospital
Giza, 12573, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- LECTURER OF CLINICAL PHARMACY
Study Record Dates
First Submitted
April 7, 2023
First Posted
April 20, 2023
Study Start
August 24, 2023
Primary Completion
January 1, 2026
Study Completion
February 1, 2026
Last Updated
July 31, 2025
Record last verified: 2025-07