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IRCT20230615058488N1 IRCT 2023-06-22 Mashhad University of Medical Sciences Investigating the effect of apricot kernel oil on primary dysmenorrhea Investigating the effect of oral capsule of Apricot Kernel seed oil on primary dysmenorrhea 2023-07-06 anticipated 60 Complete https://irct.ir/trial/70738 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random allocation by coin flipping method According to the order of entering the samples into the research, people with odd numbers will be given medicine A and people with even numbers will be given medicine B. For example, the first person entered into the study receives drug number 1 and drug A, and the second person receives drug number 2 and drug B. One of the two drugs A and B is apricot kernel oil and the other is a capsule similar to placebo. It should be mentioned that the determination of the medicine is done by lottery, Blinding description: In this research, sufficient explanations about the study and that the people will be divided into two groups are given to the subjects. The first person entered into the study is given drug A and the second person is given drug B. It should be noted that the people involved in the research, the project manager, the main researcher, the statistical consultant professor do not know which of the two drugs A and B are apricot kernel oil and which one is the placebo. Only the pharmacist consultant is aware of this matter. 3 Primary dysmenorrhea. Intervention 1: Intervention group: Students with primary dysmenorrhea who take 900 mg apricot kernel oil oral soft gelatin capsule for 2 menstrual cycles and each cycle for 5 days (2 days before menstruation to 3 days after menstruation). Intervention 2: Control group: Students with primary dysmenorrhea who take the placebo soft gelatin capsule, which is the same shape and size as the apricot kernel oil capsule, for 2 menstrual cycles and each cycle for 5 days (2 days before the onset of menstruation to 3 days after the onset of menstruation) they consume. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mahboobeh Firoozi
Faculty of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 firoozim@mums.ac.ir Mashhad University of Medical Sciences scientific Mahboobeh Firoozi
Faculty of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 firoozim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age 18 to 35 years, being single, the onset of menstrual pain before the age of 20 (primary dysmenorrhea usually affects girls under 20 years old), experiencing pain and symptoms of moderate and severe dysmenorrhea, monthly bleeding and its regularity with intervals of 21 to 35 days, Low and moderate bleeding during menstruation (absence of clot discharge), not suffering from chronic diseases (diabetes, hyperthyroidism and hypothyroidism, chronic liver or kidney disease and diagnosed depression, not having a history of gastric or duodenal ulcers), not having a positive history of pelvic inflammatory diseases , myoma and pelvic tumors, not having a history of gynecological surgery or abdominal surgery (including any type of open surgery or laparotomy and laparoscopy in the pelvic area such as cysts, masses, adhesions), not using oral contraceptives, benzodiazepines, barbiturates, narcotics , some antidepressants such as fluoxetine and anticoagulants, not consuming alcohol, not having symptoms such as burning, itching and abnormal discharge in the genital area, not having a history of allergies to medicinal plants, not having experienced major stressors such as the separation of parents or the death of a first-degree relative in In the last six months, not being forced to consume a special diet and professional and heavy sports, not smoking, not having plans to transfer, move, party in another university or graduate during the study period. 18 years 35 years Female In the event of: unwillingness to continue the research, failure to use the correct medicinal supplement and use of any medication effective on dysmenorrhea, the duration of dysmenorrhea is longer than the normal time defined for primary dysmenorrhea. N94.4 Primary dysmenorrhoea Treatment - Drugs Placebo Intervention group: Students with primary dysmenorrhea who take 900 mg apricot kernel oil oral soft gelatin capsule for 2 menstrual cycles and each cycle for 5 days (2 days before menstruation to 3 days after menstruation). Control group: Students with primary dysmenorrhea who take the placebo soft gelatin capsule, which is the same shape and size as the apricot kernel oil capsule, for 2 menstrual cycles and each cycle for 5 days (2 days before the onset of menstruation to 3 days after the onset of menstruation) they consume Dysmenorrhoea pain intensity. Timepoint: The beginning of the study, the end of the first menstrual cycle and the end of the second menstrual cycle. Method of measurement: Visual Analogue Scale. Frequency of physical symptoms of dysmenorrhea. Timepoint: The beginning of the study, the end of the first menstrual cycle and the end of the second menstrual cycle. Method of measurement: Standard verbal multidimensional scoring system. Duration of primary dysmenorrhoea pain. Timepoint: The beginning of the study, the end of the first menstrual cycle and the end of the second menstrual cycle. Method of measurement: Cox Menstrual Scale. The amount of menstrual bleeding. Timepoint: Before starting the intervention, the end of the first menstrual cycle and the end of the second menstrual cycle. Method of measurement: Higham chart. Mashhad University of Medical Sciences Approved 2023-05-30 Ethics committee of Mashhad University of Medical Sciences Unit 14, No 5, Arian building, Majidiyeh 33/8 street Mashhad Razavi Khorasan Iran (Islamic Republic of)