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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05821075
Other study ID # PRC-Ph-2211038
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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