Thyme Honey for Management of Oral Lichen Planus

NCT06810752 — Phase 1 / Phase 2, Enrolling by invitation, 30 participants, British University In Egypt

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Thyme Honey for Management of Oral Lichen Planus: A Non- Inferiority Controlled Randomized Clinical Trial

Registry	NCT06810752
Status	Enrolling by invitation
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	30 (Estimated)
Sponsor	British University In Egypt (Other)
Conditions	Oral Lichen Planus
Interventions	thyme honey, Triamcinolone Acetonide (Dietary supplement, drug)
Dates	start 2024-10-12, primary completion 2025-02-01 (estimated), completion 2025-03-01 (estimated), first posted 2025-02-06, last updated 2025-02-06
Locations	1 site in Egypt

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Thyme Honey group	Active comparator	Dietary Supplement: thyme honey	Topical application of Thyme Honey
Control group	Placebo comparator	Drug: Triamcinolone Acetonide	Topical application of Triamcinolone acetonide

thyme honey (Dietary supplement): Topical application on the oral mucosa
Triamcinolone Acetonide (Drug): Topical application on the oral mucosa

+Outcome measures

Primary outcomes

VAS score assessement [1 month]: Pain intensity

Secondary outcomes

measurement of salivary level of miRna155 [1 month]

+Eligibility

Sex: All

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.

+Locations (1)

Facility	City	Country	Status
The British university in Egypt	Cairo	Egypt