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

• Sponsor: October 6 University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05821075
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Bell Palsy	Drug: Prednisolone; Drug: Cerebrolysin	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Study Between Prednisolone, Cerebrolysin in the Treatment of Bell's Palsy
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prednisolone	Drug: Prednisolone; prednisolone 60mg tablet once daily for 5 days then tapering dose
Active Comparator: Cerebrolysin	Drug: Cerebrolysin; intramuscular Cerebrolysin 10 mg daily for 3 weeks
Active Comparator: Prednisolone and Cerebrolysin	Drug: Prednisolone; prednisolone 60mg tablet once daily for 5 days then tapering dose; Drug: Cerebrolysin; intramuscular Cerebrolysin 10 mg daily for 3 weeks

Outcome Measures

Primary Outcome Measures

1. change in scores of the house Brackman grading system HB [at baseline, after 1 week, after 3 week]

2. changes in scores of the Sunnybrook grading system. [at baseline, after 1 week, after 3 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	October 6 university hospital	Giza		Egypt	12573

Sponsors and Collaborators

• October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: engy wahsh, LECTURER OF CLINICAL PHARMACY, October 6 University
• ClinicalTrials.gov Identifier: NCT05821075
• Other Study ID Numbers: PRC-Ph-2211038
• First Posted: Apr 20, 2023
• Last Update Posted: Apr 20, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bell Palsy; Facial Paralysis; Prednisolone; Cerebrolysin

Study Results

No Results Posted as of Apr 20, 2023