Efficacy of Prednisolone Versus Cerebrolysin in the Treat... | NCT05821075

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

NCT05821075

Sponsor

October 6 University

Status

Recruiting

Last Update Posted

Jul 31, 2025Actual

Enrollment

90Estimated

Phase

Phase 1Phase 2

Conditions

Bell Palsy

Interventions

Prednisolone
Cerebrolysin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2023Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Feb 2026Estimated

First Submitted Date

Apr 7, 2023

First Submission Date that Met QC Criteria

Apr 7, 2023

First Posted Date

Apr 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2025

Last Update Posted Date

Jul 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Prednisolone	Active Comparator	Drug: Prednisolone
Cerebrolysin	Active Comparator	Drug: Cerebrolysin
Prednisolone and Cerebrolysin	Active Comparator	Drug: Prednisolone Drug: Cerebrolysin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prednisolone	Drug	prednisolone 60mg tablet once daily for 5 days then tapering dose	Prednisolone Prednisolone and Cerebrolysin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in scores of the house Brackman grading system HB		at baseline, after 1 week, after 3 week
changes in scores of the Sunnybrook grading system.		at baseline, after 1 week, after 3 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Engy Wahsh	Contact	01003095692		engywahsh@o6u.edu.eg
mohamed rez	Contact	01006904056		Abdelmaksodm.mousa@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
October 6 university hospital	Recruiting	Giza		12573	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D020330	Bell Palsy

Ancestor Terms

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011239	Prednisolone
C006952	cerebrolysin

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided