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IRCT20231017059753N2 IRCT 2024-01-18 Ahvaz University of Medical Sciences the effect of Hypericum perforatum Plant oil on the severity pain of primary dysmenorrhea the effect of Hypericum perforatum Plant oil on the severity pain of primary dysmenorrhea 2024-02-19 anticipated 100 Complete https://irct.ir/trial/74589 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be in the form of random block sampling based on the purpose and according to the study entry criteria. We consider the block size to be 5. Therefore, based on the sample size, we will have 20 blocks. When sampling starts, the first block will be randomly assigned one of the codes A or B. Based on the received code of the first block, the second code will be sent to the second block, the first code will be sent to the third block, the second code will be sent to the fourth block, and so on until the end of the 20th block, Blinding description: Hypericum perforatum oil and paraffin oil (placebo) will be matched by the pharmacist in terms of appearance, color, size, smell, and code (A and B). The researcher, the service provider, the data analyst, and the patient are unaware of the type of drug used, and only the pharmacist will be aware of this coding. 3 Primary dysmenorrhea. Intervention 1: Intervention group: Intervention group: The drug used for the intervention group is hofaricon oil. This drug was manufactured by Danesh Banyan Zardband company with high quality and was purchased from this company. The patient will be instructed to apply 5 drops of the oil from 5 days before menstruation to 2 days after the onset of menstruation and for 2 consecutive cycles and every day 5 drops locally for 15 minutes on the upper part of the pubis. The face should be massaged circularly from the center point to the size of the palm. Intervention 2: Control group: Control group: The drug used for the control group is paraffin oil. The patient will be instructed to apply 5 drops of the oil from 5 days before menstruation to 2 days after the onset of menstruation and for 2 consecutive cycles and every day 5 drops locally for 15 minutes on the upper part of the pubis. The face should be massaged circularly from the center point to the size of the palm. 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 leila bozorgian
Ahvaz, Golestan, North Esfand St
Ahvaz Iran (Islamic Republic of) 15794- 61357 +98 61 3314 0000 journal_ajums@yahoo.com Ahvaz University of Medical Sciences scientific leila bozorgian
Ahvaz, Golestan, North Esfand St
Ahvaz Iran (Islamic Republic of) 15794- 61357 +98 61 3314 0000 liela.bozorgian1@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Suffering from grade 2 and 3 primary dysmenorrhea according to verbal multidimensional criteria Female students aged 17-30 years Absence of medical illness (diabetes, blood pressure, epilepsy, any kind of heart disease, rheumatism, and neurological diseases...) Has grade 2 and 3 primary dysmenorrhea based on multidimensional speech criteria Full consent to participate in the studyf Regular menstrual cycles with intervals of 21 to 35 days6- Menstrual bleeding without clots (light and moderate bleeding) Menstrual bleeding without clots (light and moderate bleeding) The onset and duration of primary dysmenorrhea from a few hours before menstruation to the second day of bleeding - Not using anticoagulants, narcotics, benzodiazepines Not using contraceptive pills, painkillers and other herbal medicines as well as relaxation methods or acupressure to relieve primary dysmenorrhea. History of allergy to herbal medicines Absence of stressful factors in the last two months, special dietary needs - No history of pelvic inflammatory disease, myoma and pelvic tumors 17 years 30 years Female Continuous use of nutritional supplements and vitamins N73.8 Other specified female pelvic inflammatory diseases Treatment - Drugs Placebo Intervention group: Intervention group: The drug used for the intervention group is hofaricon oil. This drug was manufactured by Danesh Banyan Zardband company with high quality and was purchased from this company. The patient will be instructed to apply 5 drops of the oil from 5 days before menstruation to 2 days after the onset of menstruation and for 2 consecutive cycles and every day 5 drops locally for 15 minutes on the upper part of the pubis. The face should be massaged circularly from the center point to the size of the palm. Control group: Control group: The drug used for the control group is paraffin oil. The patient will be instructed to apply 5 drops of the oil from 5 days before menstruation to 2 days after the onset of menstruation and for 2 consecutive cycles and every day 5 drops locally for 15 minutes on the upper part of the pubis. The face should be massaged circularly from the center point to the size of the palm. Intensity of pain. Timepoint: Subjects will fill the questionnaires half an hour after oil massage during the second day of menstruation in both consecutive cycles. Method of measurement: McGill pain questionnaire. Ahvaz University of Medical Sciences Approved 2023-12-15 Ethics Committee of Ahvaz University of Medical Sciences Ahvaz Golestan, North Esfand St Ahvaz Khouzestan Iran (Islamic Republic of)