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IRCT20230702058648N1 IRCT 2023-08-21 Mashhad University of Medical Sciences Investigating the effect of frankincense capsules on premenstrual syndrome and menstrual pain Investigating the effect of frankincense capsules on premenstrual syndrome and primary dysmenorrhea of students of Mashhad University of Medical Sciences 2023-10-07 anticipated 62 Complete https://irct.ir/trial/71716 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple. Allocation Concealment method: In order to conceal, frankincense and placebo oral capsules are provided to the researcher by the pharmacist consultant in similar forms (appearance, color and packaging) and with two different codes, and only the pharmacist consultant knows about it. The method used to generate a random allocation sequence by mentioning the name of the software or site used: After confirming the presence of premenstrual syndrome and early dysmenorrhea in the research units and according to the entry and exit criteria, people will be randomly assigned to two groups using the PASS software, Blinding description: Allocation Concealment method: In order to conceal, frankincense and placebo oral capsules are provided to the researcher by the pharmacist consultant in similar forms (appearance, color and packaging) and with two different codes, and only the pharmacist consultant knows about it. 2 Condition 1: Dysmenorrhea. Condition 2: Premenstrual Syndrome. Intervention 1: Intervention group: In the intervention group, oral oregano capsules will be used once a day from 7 days before menstruation to the first 3 days of menstruation. Intervention 2: Control group: In the control group, the placebo capsule will be used once a day from 7 days before menstruation to the first 3 days of menstruation. 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 Mohaddeseh Borhaninasab
Mashhad Faculty of Nursing and Midwifery., Ibn-e Sina St., Doktora Crossing., Mashhad., Iran
Mashhad Iran (Islamic Republic of) ErfanianF@mums.ac.ir +98 51 3859 1511 Borhaninasabm4001@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Erfanian
Nursing and Midwifery University, Ibn Sina St.
Mashhad Iran (Islamic Republic of) 9137913199 0513591511 ErfanianF@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 1. Age 18 to 35 years. 2. Regular menstrual cycles. 3. Suffering from premenstrual syndrome and primary moderate to severe dysmenorrhea at the same time. 4. Being single. 5. Resident in the dormitory of Mashhad University of Medical Sciences. 6. Not taking certain drugs. 7. Not using alcohol or drugs and tobacco. 8. Not having depression, anxiety and extreme stress. 9. Lack of diet. 10. Not using medicinal and traditional treatments to reduce the symptoms of premenstrual syndrome and dysmenorrhea. 11. BMI less than 30. 12. Absence of specific medical disease. 13. Absence of known gynecological issues such as fibroids and endometriosis. 14. The absence of stressful events in the past 6 months. 15. Not engaging in sports professionally. 18 years 35 years Female 1. Age 18 to 35 years. 2. Regular menstrual cycles. 3. Suffering from premenstrual syndrome and primary moderate to severe dysmenorrhea at the same time. 4. Being single. 5. Resident in the dormitory of Mashhad University of Medical Sciences. 6. Not taking certain drugs. 7. Not using alcohol or drugs and tobacco. 8. Not having depression, anxiety and extreme stress. 9. Lack of diet. 10. Not using medicinal and traditional treatments to reduce the symptoms of premenstrual syndrome and dysmenorrhea. 11. BMI less than 30. 12. Absence of specific medical disease. 13. Absence of known gynecological issues such as fibroids and endometriosis. 14. The absence of stressful events in the past 6 months. 15. Not engaging in sports professionally. N94.4 N94.3 Primary dysmenorrhea Premenstrual tension syndrome Treatment - Drugs Placebo Intervention group: In the intervention group, oral oregano capsules will be used once a day from 7 days before menstruation to the first 3 days of menstruation. Control group: In the control group, the placebo capsule will be used once a day from 7 days before menstruation to the first 3 days of menstruation. Average total score of premenstrual syndrome symptoms. Timepoint: Calculation of the average score of premenstrual syndrome symptoms at the beginning of the study (before the start of the intervention) and 1 and 2 months after the start of the intervention. Method of measurement: The mean total score of premenstrual syndrome symptoms will be evaluated by the Calendar of Premenstrual Events (COPE) form, as self-reported by the patients. Average total score of severity and duration of primary dysmenorrhea. Timepoint: Calculation of the average score of severity and duration of dysmenorrhea at the beginning of the study (before the start of the intervention) and 1 and 2 months after the start of the intervention. Method of measurement: The mean total score of dysmenorrhea intensity by the visual pain scale (VAS) and the mean total score of pain duration by the scale COX menstrual scale will be investigated in the form of self-reporting by patients. Mashhad University of Medical Sciences Approved 2023-07-25 Ethics committee of Mashhad University of Medical Sciences Mashhad Faculty of Nursing and Midwifery, Ibn-e Sina St., Doktora Crossing., Mashhad., Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)