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IRCT20240212060964N1 IRCT 2024-03-06 Tehran University of Medical Sciences The effectiveness of Pomegranate flower on oral lichen lesions Formulation and standardization of mucoadhesive form of Golnar (Punica granatum L.) and its effectiveness in erythematous and erosive lesions of oral lichen planus and its comparison with mucoadhesive form of triamcinolone: a randomized double-blind clinical trial 2024-05-21 anticipated 40 Complete https://irct.ir/trial/75452 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method will be used using blocks of 4. A person who is not involved in the process of taking patients and evaluating patients will create a random sequence using the site: https://www.sealedenvelope.com And based on the sample size, 15 blocks of 4 will be created. Each patient will be given a unique code that can be created on this site. Therefore, the concealment is observed and the patients and people involved in the study do not know in which group the next person will be placed and they will not know about the random sequence and only the statistics consultant will know about the random sequence and the codes will remain with them, Blinding description: Medicines and placebo are in similar containers with the same shape, color and smell. Specific codes are inserted by a third person on the label of the medicine box and placebo. Patients and researchers do not know the concept of codes.با. 3 Erythematous and erosive lesions of oral lichen planus. Intervention 1: Intervention group: 20 patients who receive the mucoadhesive form containing Golnar 3 times a day. Intervention 2: Control group: 20 patients who receive triamcinolone mucoadhesive form 3 times a day. Yes - There is a plan to make this available What will be shared: All non-personal data of participants without mentioning names; Information about the main messages and all the information obtained from the research is published in the article When: in the relevant article after its publication To whom: Everyone who has access to the published article Conditions: After publication in the journal Where to obtain: to the text of the published article How to obtain: send e-mail to zmoravej@razi.tums.ac.ir Comments:
public Seyede Zahra Moravej
No. 27, North Sarparast St., West Taleghani St
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 8378 szm1376@gmail.com Tehran University of Medical Sciences scientific Seyede Zahra Moravej
No. 27, North Sarparast St., West Taleghani St
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 8378 szm1376@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Existence of clinical criteria and pathology of erythematous and erosive lesions of oral lichen planus 18 years no limit Both Patients with a history of chronic diseases such as hypertension, diabetes, etc. Active viral disease in the oral mucosa Patients with a history of allergy to herbal medicines-receiving local treatment in the last 2 weeks or systemic treatment in the last 4 weeks for lesions of oral lichen planus L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: 20 patients who receive the mucoadhesive form containing Golnar 3 times a day Control group: 20 patients who receive triamcinolone mucoadhesive form 3 times a day. - Determining the formulation of the adhesive mucus form containing Golnar- Determining the pH of the form of glue containing Golnar- Determining the release of the extract from the adhesive mucus ointment containing Golnar- Determining the amount of adhesiveness of the adhesive mucus form containing Golnar- Determining the rheological properties of the form of glue containing Golnar- Determining the microbial stability of the adhesive mucus form containing Golnar- Comparison of the average pain score of lichen planus between two groups of adhesive mucus form containing Golnar and triamcinolone adhesive form- Comparison of the average lichen plan score between the two groups of adhesive mucus form containing Golnar and triamcinolone adhesive mucus- Comparison of the frequency of lichen planus lesions between the two groups of adhesive mucus form containing golnar and triamcinolone adhesive mucus- Comparison of the average score of response to lichen planus treatment between two groups of adhesive mucus form containing Golnar and triamcinolone adhesive mucus- Comparison of the average duration of treatment of lichen planus between two groups of adhesive mucus form containing Golnar and triamcinolone adhesive mucus- Comparison of the average Lichen Plan pain score within each group before and after treatment- Comparison of the average score of Lichen Plan within each group before and after treatment- Comparison of the frequency of lichen planus lesions in each group before and after treatment- Comparison of the mean response score to lichen planus treatment within each group before and after treatment. Timepoint: The beginning of the study, 2, 4, 6 and 8 weeks after the start of the study. Method of measurement: - Pain ruler or Visual Analog Scale (VAS): A scaled page from 0 to 10 is given to the patients and according to the pain intensity of the lesions, a numerical score between 0 (in the absence of pain) and 10 (the most severe) is given.- The largest diameter of each lesion is measured by a specialist using calipers and (or dental floss for lesions far from reach). The REU scoring system (reticular/hyperkeratotic, erosive/erythematous, ulcerative) will be used to evaluate lesions.- Side effects form based on (CTCAE) Common Terminology Criteria for Adverse Version 5 is completed for patients on days 7, 14, 28. Tehran University of Medical Sciences Approved 2024-02-07 Biomedical Research Ethics Committee 6th floor, Central Organization of Tehran University of Medical Sciences, corner of Qods St, Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)