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IRCT20250911067210N2 IRCT 2025-09-30 Tehran University of Medical Sciences The effect of herbal medicine on oral lichen planus study HMOLPS 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 2025-10-17 anticipated 50 Complete https://irct.ir/trial/86142 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Oral lichen planus. Intervention 1: Intervention group: Chamomile and marshmallow oral gel (5% aqueous extract of chamomile flowers and 5% of marshmallow aerial parts (flowers)) four times a day topically for two months. Intervention 2: Control group: Oral triamcinolone topical, four times a day for two months. Yes - There is a plan to make this available What will be shared: Information about patients and the main outcome can be shared. When: 6 months after publication and printing of results To whom: Researchers working in academic and scientific institutions and people working in industry Conditions: For use in other studies or to design new studies Where to obtain: Professor Mehrdad Karimi mehrdadkarimi@yahoo.com 00982188976527 How to obtain: The request is registered via email and is responded to after review by members of the research team. Comments:
public Azadeh Zarei
Ahmadieh Health Center, Tabriz Alley, North Sarparast Street, Taleghani Street
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 6527 drzarei.azadeh@gmail.com Tehran University of Medical Sciences scientific Azadeh Zarei
Ahmadieh Health Center, Tabriz Alley, North Sarparast Street, Taleghani Street
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8897 6527 drzarei.azadeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of lichen planus by a dermatologist Patients with positive pathology Mild to moderate oral lesions no limit no limit Both People with immunodeficiency Diabetes Pregnancy Osteomyelitis Peripheral vascular disease Use of systemic medications Severe degrees of oral lichen planus lesions L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: Chamomile and marshmallow oral gel (5% aqueous extract of chamomile flowers and 5% of marshmallow aerial parts (flowers)) four times a day topically for two months Control group: Oral triamcinolone topical, four times a day for two months Change in lesion severity on examination based on REU score. Timepoint: Before the start of the intervention, and then after the intervention at specific time periods (0, 1, 2, and 3 months after the intervention) on a monthly basis. Method of measurement: Clinical exam. Tehran University of Medical Sciences Approved 2025-07-22 Ethics Committee of Tehran University of Medical Sciences, Institute of Pharmaceutical Sciences, Teh Ahmadieh Health Center, Tabriz Alley, North Sarparast Street, Taleghani Street Tehran Tehran Iran (Islamic Republic of)