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

October 6 University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Bell Palsy

Treatments: Drug: Cerebrolysin; Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05821075

PRC-Ph-2211038

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Prednisolone

Active Comparator group

Treatment:

Drug: Prednisolone

Cerebrolysin

Active Comparator group

Treatment:

Drug: Cerebrolysin

Prednisolone and Cerebrolysin

Active Comparator group

Treatment:

Drug: Prednisolone

Drug: Cerebrolysin