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Recruiting NCT05821075

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

Phase I / Phase II Interventional Bell Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prednisolone, Cerebrolysin.
Who it may be relevant to
Registry conditions: Bell Palsy. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Study Between Prednisolone, Cerebrolysin in the Treatment of Bell's Palsy

Overview

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

Interventions

  • Drug Prednisolone
    prednisolone 60mg tablet once daily for 5 days then tapering dose
  • Drug Cerebrolysin
    intramuscular Cerebrolysin 10 mg daily for 3 weeks

Primary outcome measures

  • change in scores of the house Brackman grading system HB [Time frame: at baseline, after 1 week, after 3 week]
  • changes in scores of the Sunnybrook grading system. [Time frame: at baseline, after 1 week, after 3 week]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • October 6 university hospital — Giza

Identifiers

NCT: NCT05821075 · PRC-Ph-2211038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗