Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy

NCT ID: NCT05821075

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-24

Study Completion Date

2026-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Bell Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Prednisolone

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

prednisolone 60mg tablet once daily for 5 days then tapering dose

Cerebrolysin

Group Type ACTIVE_COMPARATOR

Cerebrolysin

Intervention Type DRUG

intramuscular Cerebrolysin 10 mg daily for 3 weeks

Prednisolone and Cerebrolysin

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

prednisolone 60mg tablet once daily for 5 days then tapering dose

Cerebrolysin

Intervention Type DRUG

intramuscular Cerebrolysin 10 mg daily for 3 weeks

Interventions

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Prednisolone

prednisolone 60mg tablet once daily for 5 days then tapering dose

Intervention Type DRUG

Cerebrolysin

intramuscular Cerebrolysin 10 mg daily for 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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October 6 University

OTHER

Sponsor Role lead

Responsible Party

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engy wahsh

LECTURER OF CLINICAL PHARMACY

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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October 6 university hospital

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Engy Wahsh

Role: CONTACT

01003095692

mohamed rez

Role: CONTACT

01006904056

Facility Contacts

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Abdelmaksod Mohammed Mousa, MD

Role: primary

Other Identifiers

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PRC-Ph-2211038

Identifier Type: -

Identifier Source: org_study_id

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