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IRCT20230406057831N1 IRCT 2023-06-13 Ahvaz University of Medical Sciences Comparison of the effect of passiflora plant and mefenamic acid on primary dysmenorrhoea گل ساعتی و دیسمنوره اولیه Comparison of the effect of Passiflora (Relax Herb) capsule and mefenamic acid capsule on primarydysmenorrhea 2023-05-21 anticipated 165 Complete https://irct.ir/trial/69560 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Method: Block Random unit: individual Stochastic tools: statistical software For concealment, we use random allocation concealment, in such a way that the assigned group is not known before the individual is allocated. By using non-transparent envelopes sealed with a random sequence, in this method, each of the random sequences created on the outer surface of the envelopes is numbered, and finally the lids of the envelopes are glued and placed in a box respectively. 3 Dysmenorrhea. Intervention 1: Intervention group:. Intervention 2: Control group:. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Simin Montazeri
Koi Ustadan Ahvaz and on West Coast Boulevard, Golestan Boulevard
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 0000 montazeri-s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Dr. Simin Montazeri
Koi Ustadan Ahvaz and on West Coast Boulevard, Golestan Boulevard
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 0000 montazeri-s@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) single age 18-25 years old regular menstrual cycle (25-30 days) occurrence of pain before or at the same time as menstrual bleeding moderate to severe pain intensity (4 to 10 points) based on visual analogue pain index in three days at First, menstrual bleeding no history of abdominal and pelvic surgery no symptoms such as burning, itching or abnormal secretions no stressful factors such as the death of 1st degree relatives separation of parents, etc. in the last 6 months no smoking no drug allergy 18 years 25 years Female body mass index above 30 sensitivity to non-steroidal anti-inflammatory drugs such as mefenamic acid use of oral contraceptives, supplements or any drug and herbal decoction suffering from medical diseases such as organ disease. Genital, heart, lung disease, endocrine disorders, metabolic disease, gastric or duodenal ulcer, digestive, liver and kidney disease use of drugs that suppress the central nervous system, anticoagulants and antihypertensive drugs suffering from mental illnesses. According to the patient, it is like depression, severe anxiety and severe stress Treatment - Drugs Placebo Intervention group: Control group: Severity of primary dysmenorrhoea. Timepoint: Measurement of primary dysmenorrhea before the start of the study and in the first three days of menstruation for two months. Method of measurement: Visual analog scale of pain. Duration of primary dysmenorrhea. Timepoint: Measuring the duration of primary dysmenorrhea before the start of the study and in the first three days of menstruation for two months. Method of measurement: The duration of primary dysmenorrhea is measured in minutes. Ahvaz University of Medical Sciences Approved 2023-05-01 Ethics committee of Ahvaz Jundishapur University of Medical Sciences No. 22, Abuzar Ave, 45 metry, Golshahr Town Karaj Alborz Iran (Islamic Republic of)