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

Bell Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821075
• Other study ID #: PRC-Ph-2211038
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 24, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: October 6 University
• Contact: Engy Wahsh
• Phone: 01003095692
• Email: engywahsh[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis

Intervention

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

Locations

Country	Name	City	State
Egypt	October 6 university hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in scores of the house Brackman grading system HB		at baseline, after 1 week, after 3 week
Primary	changes in scores of the Sunnybrook grading system.		at baseline, after 1 week, after 3 week