The goal of this clinical trial is to assess Honey in orabase (1:1) for treating patients with OLP and improving their quality of life:

The research question aims to answer:

Does honey in orabase (1:1) improve or reduce OLP symptoms compared to the standardized treatment by triamcinolone acetonide 0.1% drug and improve the patient's quality of life?

Participants will:

Take drug ABC or a placebo every day for 4 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler

The study comprised 56 patients diagnosed with Oral Lichen Planus, who were randomly selected according to inclusion and exclusion criteria. The subjects were between 35 and 60 years old, capable of complying with the study procedure, and provided informed consent. Exclusion criteria encompassed those with alternative oral mucosal illnesses, systemic problems influencing OLP or wound healing, allergies or sensitivities to honey or triamcinolone, or those receiving systemic corticosteroids or immunosuppressive drugs. Individuals who were pregnant or lactating, as well as those unable to provide informed written consent, were excluded.

Inclusion Criteria:

• Patients with a clinical diagnosis of oral lichen planus
• Symptomatic OLP lesions (erosive/atrophic)
• Participants are between 35 and 60 years old, who are able to adhere to the study protocol, and sign informed consent.

Exclusion Criteria:

• Patients with other oral mucosal disorders, or systemic conditions influencing OLP or wound healing, allergies or hypersensitivity to honey or triamcinolone
• Patients who administer systemic corticosteroids or immunosuppressive agents.
• Pregnancy or lactation
• Inability to comprehend or adhere to study directives
• Patients who are not able to sign an informed written consent

will be made available to researchers upon reasonable request, in order to support further research and meta-analyses.

Data to be Shared:

Demographic data (e.g., age, gender)

Baseline clinical characteristics

Treatment allocation (coded)

Outcome measures (e.g., clinical response, pain scores, lesion size)

Adverse events and safety data

Follow-up assessments

Supporting Documents:

Study protocol

Statistical analysis plan

Informed consent form (redacted)

Case report forms (CRFs)

IPD will be available beginning 6 months following publication and for up to 5 years. Data will be shared through secure data repositories or direct communication with the corresponding author, after review and approval of a formal data request, including a data use agreement.

Access to IPD will be granted to qualified researchers affiliated with academic institutions, healthcare organizations, or non-profit research entities. Requests must include:

A research proposal with clear scientific objectives and methods

Evidence of ethical approval (if applicable)

A signed data use agreement ensuring confidentiality, data protection, and responsible data handling

Agreement not to attempt to re-identify individual participants

Requests will be evaluated by the study team based on scientific merit, ethical considerations, and alignment with the purpose of the original study.

This was a double-blind, parallel-group clinical trial. Both participants and outcome assessors were blinded to the intervention. The honey in orabase and triamcinolone formulations were prepared to appear similar in color, texture, and packaging to ensure concealment. Identical containers were used for both treatments, and labeling was done using coded identifiers maintained by a third party not involved in the assessment or data analysis. Participants were instructed to apply the provided formulation as directed without being informed of the specific treatment assignment.