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IRCT20181208041882N11 IRCT 2023-10-10 Yazd University of Medical Sciences The effect of ondansetron in reducing capsaicin inflammation Evaluation of ondansetron efficacy in reducing capsaicin-induced inflammation: a randomized crossover clinical trial. 2020-02-20 anticipated 25 Complete https://irct.ir/trial/66222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: In this study, participants were randomly and periodically in one of the four groups of formulations containing a fixed amount of 0.075% of capsaicin and different amounts of ondansetron (zero (A), 0.75% (B), 31.1% (C) and 1.88 percent (D). In order to randomize, the block random allocation method was used. In this study, 5 blocks of 5 were considered. The permutations produced include the letters C, B, A and D are repeated. These permutations were produced with the help of Random allocation software version 1. For this purpose, the list prepared by the software is from number 1 to 25, which are placed in 5 blocks of five. The implementation of this software output will give the first qualified person number 1 and the last person will receive number 25, Blinding description: In this study, the patients, the clinical caregiver and the outcome assessor were not aware of the type of medication the patients received. The patients received the medications in the same packaging. 3 Inflammation caused by capsaicin. Intervention 1: Intervention group 1: Volunteers use a cream containing 0.075% capsaicin and 0.75% ondansetron (manufactured in Yazd Faculty of Pharmacy) for 3 days and 4 times a day on their knees. Intervention 2: Intervention group 2: Volunteers use a cream containing 0.075% capsaicin and 1.31% ondansetron (manufactured in Yazd Faculty of Pharmacy) for 3 days and 4 times a day on their knees. Intervention 3: Intervention group 3: Volunteers use a cream containing 0.075% capsaicin and 1.88% ondansetron (manufactured in Yazd Faculty of Pharmacy) for 3 days and 4 times a day on their knees. Intervention 4: Control group: Volunteers use a cream containing 0.075% of capsaicin and no ondansetron (manufactured in Yazd Faculty of Pharmacy) for 3 days and 4 times a day on their knees. Yes - There is a plan to make this available What will be shared: After nonrecognition, all data can be share When: 6 months after publication To whom: All of researchers Conditions: Nothing Where to obtain: Behrooz Heydari email: b.heydari@ssu.ac.ir How to obtain: Request your information by email. The data will be sent after a week. Comments:
public Behrooz Heydari
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3410 b.heydari@ssu.ac.ir Yazd University of Medical Sciences scientific Behrooz Heydari
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3410 b.heydari@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Age above 18 years Insensitivity to capsaicin 18 years 65 years Both Hypersensitivity to capsaicin Pregnancy Breastfeeding Occurrence of side effects during the study Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Volunteers use a cream containing 0.075% capsaicin and 0.75% ondansetron (manufactured in Yazd Faculty of Pharmacy) for 3 days and 4 times a day on their knees. Intervention group 2: Volunteers use a cream containing 0.075% capsaicin and 1.31% ondansetron (manufactured in Yazd Faculty of Pharmacy) for 3 days and 4 times a day on their knees. Intervention group 3: Volunteers use a cream containing 0.075% capsaicin and 1.88% ondansetron (manufactured in Yazd Faculty of Pharmacy) for 3 days and 4 times a day on their knees. Control group: Volunteers use a cream containing 0.075% of capsaicin and no ondansetron (manufactured in Yazd Faculty of Pharmacy) for 3 days and 4 times a day on their knees. Intensity and duration of capsaicin-induced burning. Timepoint: Days 1, 2 and 3. Method of measurement: Visual Analogue Scale. Yazd University of Medical Sciences Approved 2020-01-14 School of Medicine- Shahid Sadoughi University of Medical Sciences Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq Yazd Yazd Iran (Islamic Republic of)