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IRCT20220515054856N1 IRCT 2022-07-23 Kerman University of Medical Sciences Determining the effects of mouthwash from areal parts Alhagi sp. aerial parts extract on paraquat-induced oral ulcers in poisoned patients Determining the effects of mouthwash from areal parts Alhagi sp. aerial parts extract on paraquat-induced oral ulcers in poisoned patients 2022-06-22 anticipated 45 Complete https://irct.ir/trial/64140 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Randomization of the unit is done by block method with a block size of 4. For each of the 6 possible states for the quadruple block, the numbers are assigned as follows: ABBA (3), ABAB (2), AABB (1), BAAB (6), BABA (5), BBAA (4) using the table Random numbers, numbers between 1 and 6 are selected and the treatment allocation list is specified according to each number. To execute the generated random sequence, the method of hiding encoded boxes or cans is used. In this method, the cans are numbered according to a random sequence and inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written, is provided to the executor with the condition that the boxes are completely sealed and The researcher assigns patients to the standard intervention and treatment group based on the order of patients' admission. Tools: Creating a random sequence of 4 hiding random blocks to execute a random sequence on study participants. How to build: Randomly select the block and read the letters from right to left. The cans are the same weight and shape and will be prepared by an independent researcher. 2-3 Paraquat herbicide poisoning. Intervention 1: The first intervention group: Triamcinolone paste (made in Iran, manufacturer: Emad Darman Pars Chemical formula: C21H27FO6) which is given to the patient 3 times a day (every 8 hours) every day for a month to cover the wound surface. Intervention 2: The second intervention group : Aluminum hydroxide mouthwash + lidocaine + diphenhydramine (made in Iran, manufacturer: Iran Hormone), each person is given 10 cc 3 times a day for one month (once every 8 hours). Intervention 3: The third intervention group: Alhagi mouthwash (containing 0.1% of Kharshtar plant extract, made in the laboratory of the Faculty of Pharmacy of Kerman University of Medical Sciences) which is given to each person 3 times a day(once every 8 hours) for one month,amount of 10 CC is given from it. Yes - There is a plan to make this available What will be shared: Total data When: Starting from 6 months after the publication of the article To whom: Researchers, students and doctors Conditions: To conduct a clinical trial Where to obtain: General or scientific responsible person How to obtain: Send the proposal to the email of the person in charge Comments:
public Kerman University of Medical Sciences
Kerman, the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5700 nairimajdfaranak@gmail.com Kerman University of Medical Sciences scientific Faranak Nasiri Majd
Kerman, the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5700 nasirimajdfaranak@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Definitive use of paraquat herbicide with toxic dose (based on history, clinical examination, endoscopic findings) Patient consent to participate in the study no limit no limit Both Poisoning with other herbicides other than paraquat (based on history, clinical examination, endoscopic findings) Non-toxic dose of paraquat (endoscopy and normal tests) Patient dissatisfaction to participate in the study Patients do not cooperate to take medicine due to mouth ulcers Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group: Triamcinolone paste (made in Iran, manufacturer: Emad Darman Pars Chemical formula: C21H27FO6) which is given to the patient 3 times a day (every 8 hours) every day for a month to cover the wound surface. The second intervention group : Aluminum hydroxide mouthwash + lidocaine + diphenhydramine (made in Iran, manufacturer: Iran Hormone), each person is given 10 cc 3 times a day for one month (once every 8 hours). The third intervention group: Alhagi mouthwash (containing 0.1% of Kharshtar plant extract, made in the laboratory of the Faculty of Pharmacy of Kerman University of Medical Sciences) which is given to each person 3 times a day(once every 8 hours) for one month,amount of 10 CC is given from it. The rate of change (decrease or increase) in the size of oral lesions. Timepoint: 3, 7 and 30 days after patient visit and discharge time. Method of measurement: Pemphigus Oral Lesions Intensity Score (POLIS) Questionnaire. Evaluation of difficulty in eating due to its consistency. Timepoint: At the beginning of the study (before the intervention) and 3, 7 and 30 days after the patient's visit and discharge time. Method of measurement: Pemphigus Oral Lesions Intensity Score (POLIS) Questionnaire. Check the Speech Problem. Timepoint: At the beginning of the study (before the intervention) and 3, 7 and 30 days after the patient's visit and discharge time. Method of measurement: Pemphigus Oral Lesions Intensity Score (POLIS) Questionnaire. Check for discomfort when opening and moving the mouth. Timepoint: At the beginning of the study (before the intervention) and 3, 7 and 30 days after the patient's visit and discharge time. Method of measurement: Pemphigus Oral Lesions Intensity Score (POLIS) Questionnaire. Check for swallowing problems. Timepoint: At the beginning of the study (before the intervention) and 3, 7 and 30 days after the patient's visit and discharge time. Method of measurement: Pemphigus Oral Lesions Intensity Score (POLIS) Questionnaire. Check the number of areas involved in the oral cavity. Timepoint: At the beginning of the study (before the intervention) and 3, 7 and 30 days after the patient's visit and discharge time. Method of measurement: Pemphigus Oral Lesions Intensity Score (POLIS) Questionnaire. Measuring pain intensity. Timepoint: At the beginning of the study (before the intervention) and 3, 7 and 30 days after the patient's visit and discharge time. Method of measurement: Questionnaire,The Numeric Pain Rating Scale (NPRS). Recovery time. Timepoint: From the beginning until the recovery every 4 days. Method of measurement: follow up(Examining the patient and asking the patient). Kerman University of Medical Sciences Approved 2022-06-12 Ethics Committee of Kerman University of Medical Sciences The beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences kerman Kerman Iran (Islamic Republic of)