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IRCT20181208041882N8 IRCT 2023-10-08 Yazd University of Medical Sciences Evaluation of Mentha longifolia L on dysmenorrhea pain Evaluation of Mentha longifolia L. efficacy on decrease of dysmenorrhea pain 2018-11-27 anticipated 42 Complete https://irct.ir/trial/52095 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: In this study, 42 patients are randomly divided into three treatment groups (A ,B and C). Block random allocation method will be used for random allocation. In this study, 7 blocks of 6 are considered. The generated permutations include repeated letters A, B and C (eg ABACAB). These permutations are generated with the help of Random allocation software version 1. For this purpose, the list prepared by the software is from 1 to 42, which are arranged in 7 blocks of six regularly. To run this software output, we give the first qualified person number 1 and the last person will receive number 42. In order to be blind, the random allocation of this list is given to another person outside the study, and by sending a text message before assigning the type of treatment, the eligible person is asked according to the number, and thus the people enter the study. Also in the software output, both numbers 1 to 42 and permutations of the letters A, B and C can be seen, Blinding description: In this study patients, clinical caregivers and outcome assessors were unaware of the type of medication patients were receiving. Patients in three groups received the medication in the same package. 3 Primary Dysmenorrhea. Intervention 1: Intervention group: Patients with primary dysmenorrhoea with moderate to severe severity use one capsule of mefenamic acid every 6 hours for up to 3 days. Intervention 2: Intervention group: Patients with primary dysmenorrhoea with moderate to severe severity use two capsules of Mentha longifolia (Manufactured in Yazd Pharmacy Faculty) every 6 hours for up to 3 days. Intervention 3: Control group: Patients with primary dysmenorrhoea with moderate to severe severity use one placebo capsule (Manufactured in Yazd Pharmacy Faculty) every 6 hours for up to 3 days. 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) Women's 15 to 45 years old Moderate to severe dysmenorrhea pain 15 years 45 years Female Patients with mild or secondary dysmenorrhea pain Patients have received one of the NSAID drugs. Hypersensitivity to Mentha longifolia L Pregnancy and lactation N94.4 Primary dysmenorrhea Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Patients with primary dysmenorrhoea with moderate to severe severity use one capsule of mefenamic acid every 6 hours for up to 3 days. Intervention group: Patients with primary dysmenorrhoea with moderate to severe severity use two capsules of Mentha longifolia (Manufactured in Yazd Pharmacy Faculty) every 6 hours for up to 3 days. Control group: Patients with primary dysmenorrhoea with moderate to severe severity use one placebo capsule (Manufactured in Yazd Pharmacy Faculty) every 6 hours for up to 3 days. Dysmenorrhoea pain. Timepoint: Days 0 and 3. Method of measurement: Visual analog scale. Yazd University of Medical Sciences Approved 2018-11-27 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)