Investigating the effect of herbal products (German chamomile or"Matricaria chamomilla" and Common marshmallow or" Althaea officinalis ") based on Persian medicine compared to oral gel triamcinolone in patients with oral lichen planus: A randomizedclinical trial

effectiveness of herbal products of chamomile and marshmallow based on Iranian medicine in the treatment of oral lichen planus

A controlled, randomized,double blind, phase 2 clinical trial with parallel groups on 50 patients, using double blocks for randomization. To blind the drug for both control and control groups, the pharmacist prepares and labels it in identical packaging. These packages are prepared in the same shape, color, and form, and the physician prescribes it to the patient in a blinded manner and based on randomization based on double blocks.

In the field of dermatology, at Razi Hospital, patients will be randomly divided into two equal groups. The control group receive 0.1% triamcinolone oral paste) and the intervention group treats with chamomile and marshmallow oral gel topically four times a day. Patients will be treated for two months and then discontinued for one month. After the start of the intervention, patients will follow up monthly at specific periods (0, 1, 2, and 3 months after the intervention). Participants, physicians, and principal investigators will be blinded throughout the study.

Inclusion criteria: Patients diagnosed with lichen planus by a dermatologist, with positive pathology, and mild to moderate oral lesions. Exclusion criteria: People with immunodeficiency, diabetes, pregnancy, osteomyelitis and peripheral vascular disease, and use of systemic medications, severe oral lichen planus lesions.

The intervention group consists of individuals who are randomly selected to receive the drug under study for their oral lichen planus lesion. The control group is also cross-examined by administering a placebo versus the medicine of the intervention group.

Age; Gender; Severity of oral lichen planus lesions; Duration of disease

To minimize heterogeneity between study groups, a block randomization design was implemented to randomly assign participants. Eligible patients will be randomly assigned in a 1:1 ratio to the intervention and control groups. Randomization will be performed using a computer-assisted randomization (RAS) procedure. The sequence will be in alternating blocks of four, with patients stratified. Except for the study pharmacist who will provide the randomization list and the sequential numbering of the drug, the investigators and all patients will be unaware of this list. The allocation sequence is sealed and hidden through sequential numbering.

The principles of blinding are that both the drug and the placebo are indistinguishable in size, color, shape, weight, and packaging. The participants in the study, the prescribing physician, and the study investigators are unaware of the allocation of the drug and placebo, and only the pharmacist is aware of the allocation. To hide the drug and placebo and prevent their identification, identically shaped boxes with completely identical conditions that are randomly assigned and coded are used so that this blinding is maintained throughout the study.

Information about patients and the main outcome can be shared.

6 months after publication and printing of results

Researchers working in academic and scientific institutions and people working in industry

For use in other studies or to design new studies

Professor Mehrdad Karimi mehrdadkarimi@yahoo.com 00982188976527

The request is registered via email and is responded to after review by members of the research team.