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IRCT20200223046591N1 IRCT 2020-03-16 Esfahan University of Medical Sciences Evaluation of the effectiveness of systemic Echinacea on clinical indices of erosive oral lichen planus Evaluation of the effectiveness of systemic Echinacea on clinical indices of erosive oral lichen planus 2019-08-03 anticipated 64 Complete https://irct.ir/trial/46068 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among patients suffering from erosive oral lichen planus referred to Isfahan university of medical sciences, 64 patients who have been examined and met the eligibility criteria will enter the study and a number will be assigned to every patient. Then they will be divided into two groups using block randomization (block size=32) in the random allocation service software. For allocation concealment, sealed coded boxes with same size and weight will be used, Blinding description: Placebo and echinacea tablets will be placed in the same containers each with A or B labels on them. The patient and clinician will not know about the content of each container. Data will be given to the statistics advisor in alphabets. 2-3 Erosive oral lichen planus. Intervention 1: Intervention group: Chracteristics of the consumed substance: Echinacea herbal tablets, The chemical composition and its concentration: Each tablet contains 114 mg of dried extract of leachate shoots of Echinacea, The dose: 342 mg daily, Consumption frequency: Three times a day orally, Consumption Duration: 35 days. one spoon of mouthwash: nystatin oral drop 100000 U/G 20-25 drops,4 ampules of betamethasone suspension ,aluminium MG 1 spoon, diphenhydramine syrup 1 spoon. Intervention 2: Control group: placebo tablets; Consumption frequency: Three times a day orally, Consumption Duration: 35 days. one spoon of mouthwash: nystatin 100000 U/G 20-25 drops,4 ampule betamethasone suspension ,aluminium MG 1 spoon, diphenhydramine syrup 1 spoon. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are unrecognizable. When: 6 months After the publication of the article To whom: Researchers working in academic institutions Conditions: Use of data under the supervision and agreement of the Isfahan University of Medical Sciences vice chancellor of Research and Technology and the project implementer and to achieve the intended aims in the proposal and developing review studies Where to obtain: Dr Zahra Saberi : zahra.saberi@dnt.mui.ac.ir How to obtain: 1-Contact the project implementer via Email and make a written request for the consent to deliver the data 2-Seeking contact information of Isfahan University of Medical Sciences Vice Chancellor of research and Technology 3-Make a written request to obtain permission from Isfahan University of Medical Sciences Vice Chancellor of research and Technology 4-The data can be accessed only in person from the Department of Oral Medicine of Isfahan Dental School If there is no problem data will be accessible in 2 weeks. Comments:
public Zahra Saberi
Oral and Maxillofacial department, School of Dentistry, Isfahan University of Medical Sciences School of Dentistry, St.Hezarjarib, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5514 zahra.saberi@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Zahra Saberi
Oral and Maxillofacial department, School of Dentistry, Isfahan University of Medical Sciences School of Dentistry, St.Hezarjarib, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5514 zahra.saberi@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients sufering from erosive oral lichen planus refered to isfahan dental school department of oral medicine whose lesions are clinically and pathologically confirmed according to WHO criteria Certaining of the patient's cooperation and consent presence of at least one lichen planus lesion in oral cavity according to modified Thongprasom criteria the clinical score must be more than 1 20 years 60 years Both patients attended another clinical trial in past 3 months pregnancy and lactation presence of lichenoid reactions presence of extraoral lesions use of systemic steroid drugs, analgesics, immunomodulation drugs, NSAIDs a week before trial presence of other lesions in oral cavity history of asthma and allergy patients suffering from systemic conditions such as diabetes, TB, high blood pressure, life threatening diseases and cancer patients suffering from ulcerative colitis, entrogastric diseases, crohns syndrome, behjet`s syndrome, intensive anemia, rheumatoid arthritis, lupus, multiple sclerosis, collagen disorders, leukosis and AIDS history of organ transplantation L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: Chracteristics of the consumed substance: Echinacea herbal tablets, The chemical composition and its concentration: Each tablet contains 114 mg of dried extract of leachate shoots of Echinacea, The dose: 342 mg daily, Consumption frequency: Three times a day orally, Consumption Duration: 35 days. one spoon of mouthwash: nystatin oral drop 100000 U/G 20-25 drops,4 ampules of betamethasone suspension ,aluminium MG 1 spoon, diphenhydramine syrup 1 spoon Control group: placebo tablets; Consumption frequency: Three times a day orally, Consumption Duration: 35 days. one spoon of mouthwash: nystatin 100000 U/G 20-25 drops,4 ampule betamethasone suspension ,aluminium MG 1 spoon, diphenhydramine syrup 1 spoon Lesion size. Timepoint: At baseline(before intervention),10,25 and 35 days after using Echinacea tablets. Method of measurement: graph paper and ruler. Pain level. Timepoint: At baseline(before intervention),10,25 and 35 days after using Echinacea tablets. Method of measurement: Visual Analogue Scale index. Duration of lesion healing. Timepoint: At baseline(before intervention),10,25 and 35 days after using Echinacea tablets. Method of measurement: day. Duration of pain relief. Timepoint: At baseline(before intervention),10,25 and 35 days after using Echinacea tablets. Method of measurement: day. Esfahan University of Medical Sciences Approved 2019-07-31 Ethics committee of Isfahan University of Medical Sciences Hezar jarib St. Isfahan university of medical sciences Isfahan Isfehan Iran (Islamic Republic of)