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IRCT20150721023282N27 IRCT 2024-02-17 Esfahan University of Medical Sciences The effectiveness of russian olive in the treatment of oral aphthae Evaluation of the effectiveness of Elaeagnus angustifolia extract mucoadhesive buccal film in the treatment of oral recurrent aphthous ulcers: a randomized single-blind placebo-controlled clinical trial 2024-02-20 anticipated 34 Complete https://irct.ir/trial/74710 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method will be used using blocks of 4. For this, all cases of quadruple arrangement (including two drugs and two placebos) in a block will be designed and a code will be given to each block. The blocks will be selected using a random number table and patients are assigned to each of the two groups based on the order of the selected block, Blinding description: Drug (Elaeagnus angustifolia extract) and placebo mucoadhesie buccal film will be fully similar and packaged in similar containers. The prescriber (physician) and the data analyst will be blind to the content of containers and intervention type. 3 Oral recurrent aphthous ulcer. Intervention 1: Intervention group: mucoadhesive buccal film of Elaeagnus angustifolia extract (manufactured by the faculty of Pharmacy) standardized based on total phenol count(TPC), 4 times daily for 4 days. Intervention 2: Control group: mucoadhesive buccal film of placebo (manufactured by the faculty of Pharmacy), 4 times daily. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more data.
public Rasool Soltani
Faculty of Pharmacy, Isfahan University of Medical Sciences, Hezar-Jerib Avenue
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7067 soltani@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Rasool Soltani
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7067 soltani@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age of 18 years or more Having 1 to 5 oral aphthous ulcers No more than 48 hours of aphthous occurrence Not receiving any systemic antibiotic within the last 2 weeks 18 years no limit Both Pregnancy Lactation Underlying disease causing oral aphthous ulcer Recurrent K12.0 Treatment - Drugs Placebo Intervention group: mucoadhesive buccal film of Elaeagnus angustifolia extract (manufactured by the faculty of Pharmacy) standardized based on total phenol count(TPC), 4 times daily for 4 days Control group: mucoadhesive buccal film of placebo (manufactured by the faculty of Pharmacy), 4 times daily Oral aphthous ulcer size. Timepoint: Before the intervention, 2 and 5 days after the start of intervention. Method of measurement: Dental caliper. Pain severity. Timepoint: Before the intervention, 2 and 5 days after the start of intervention. Method of measurement: Visual Analog Scale. The number of cases with complete ulcer healing. Timepoint: End of ontervention (5th day). Method of measurement: Observation. Esfahan University of Medical Sciences Approved 2023-10-25 Ethics committee of Isfahan University of Medical Sciences Vice-chancellery for research, Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan Isfahan Isfehan Iran (Islamic Republic of)