Thyme Honey for Management of Oral Lichen Planus | NCT06810752

Studies
Thyme Honey for Management of Oral Lichen Planus

NCT06810752

Sponsor

British University In Egypt

Status

Enrolling by invitation

Last Update Posted

Feb 6, 2025Actual

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Oral Lichen Planus

Interventions

thyme honey
Triamcinolone Acetonide

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2024Actual

Primary Completion Date

Feb 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Jan 23, 2025

First Submission Date that Met QC Criteria

Feb 4, 2025

First Posted Date

Feb 6, 2025Actual

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

Feb 4, 2025

Last Update Posted Date

Feb 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the study aimed to assess the effect of topical application of thyme honey in comparison to 0.1% triamcinolone acetonide oral paste on the relief of pain and clinical improvement in patients with OLP

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thyme Honey group	Active Comparator	Topical application of Thyme Honey	Dietary Supplement: thyme honey
Control group	Placebo Comparator	Topical application of Triamcinolone acetonide	Drug: Triamcinolone Acetonide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
thyme honey	Dietary Supplement	Topical application on the oral mucosa	Thyme Honey group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS score assessement	Pain intensity	1 month

Secondary Outcomes

Measure	Description	Time Frame
measurement of salivary level of miRna155		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:• Patients clinically and histopathologically (if required) diagnosed as suffering from OLP.

Patients free from any visible oral lesions other than OLP.
Patients who agreed to take supplied medications.
Patients who agreed for the biopsy (when required).

Exclusion Criteria:• •Patients suffering from any systemic disease.

Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
Treatment with any oral topical medications for at least four weeks prior to the study.
Pregnant and lactating women.
In addition, no consideration was given to patients with a history of hypersensitivity to honey.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The British university in Egypt		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D017676	Lichen Planus, Oral

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D008010	Lichen Planus
D017512	Lichenoid Eruptions

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014222	Triamcinolone Acetonide

Ancestor Terms

ID	Term
D014221	Triamcinolone
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided