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IRCT20251016067648N1 IRCT 2025-12-15 Gonabad University of Medical Sciences The effect of taking sumac fruit powder capsules on menstrual pain and fatigue in women of reproductive age Comparison of the effects of consuming sumac fruit powder capsules with meflamic acid capsules on menstrual pain and fatigue in women of reproductive age 2026-01-09 anticipated 90 Complete https://irct.ir/trial/87281 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: In the first month of the study, women who meet the inclusion criteria will be sampled in a non-random (accessible) manner, and blocks of 6 will be used to randomly assign samples to each of the 3 groups one, two, and three. In this way, first the possible states of the blocks (CCBBAA, …, AABBCC) are listed and a number is assigned to each block. Then, randomly and proportionally to the desired sample size, the required blocks (15 blocks) are selected, and then, based on the order specified in the blocks, the individuals are assigned to the group receiving mefenamic in the first month (A), the group receiving mefenamic and sumac in the first month (B), and the group receiving sumac in the first month (C), Blinding description: In this study, in order to reduce bias and increase the validity of the results, double-blinding will be used; so that neither the participants nor the main researcher will be aware of the allocation of individuals to the intervention and control groups. The blinding process will be carried out according to the following steps: First, eligible participants will be randomly assigned to 3 groups. To maintain impartiality, this assignment will be done by an independent person who will not be involved in the data collection and analysis of the results. All participants will be informed of the consumption method in the same way, without receiving information about their assigned group. Also, the researcher who will be responsible for collecting and analyzing the data will not be aware of information related to the codes and the type of intervention. After the data collection process is completed, the codes will be opened and the data will be analyzed. Using this method will reduce the possibility of conscious or unconscious bias on the part of the researcher and participants and will increase the internal validity of the research. 2 Condition 1: Menstrual pain. Condition 2: Fatigue. Intervention 1: First intervention group: The first menstrual cycle received 250 mg mefenamic acid capsules, the second cycle received 1 gram sumac capsules, and in the third month received 1 gram sumac and 250 mg mefenamic acid capsules. It should be noted that the duration of the intervention will be the first three days of menstruation every 8 hours. Intervention 2: Intervention group 2: In the first menstrual cycle, they will receive a capsule containing 1 gram of sumac, in the second cycle, a capsule containing 1 gram of sumac and a capsule containing 250 mg of mefenamic acid, and in the third month, a capsule containing 250 mg of mefenamic acid. It should be noted that the intervention period will be every 8 hours for the first three days of menstruation each month. Intervention 3: Third intervention group: The first menstrual cycle, the recipient received 1 gram sumac capsules and 250 mg mefenamic acid capsules, the second cycle, the recipient received 250 mg mefenamic acid capsules and in the third month, 1 gram sumac capsules. It should be noted that the duration of the intervention will be the first three days of menstruation every 8 hours in each month. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information other than the publication of the article.
public Rasol Rahmani Bailandi
Golestan Dormitory, Sari Zami Blvd, Molla Sadra Blvd, Farhangian District, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165995131 +98 51 5722 5666 rasolrahmani2020@gmail.com Tabriz University of Medical Sciences scientific Roghaieh Rahmani Bailandi
No. 1, Opposite Imam Ali 4, Imam Ali Blvd., Gonabad, Khorasan Razavi Province, Iran
Gonabad Iran (Islamic Republic of) 9691997980 +98 51 5722 5666 roghaiehrahmany@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 30 years Body mass index is 18.19 to 29. Moderate (4-7) or severe (8-10) dysmenorrhea for at least one day out of the first three days of menstruation without taking medication in three consecutive cycles before the start of the study, according to the score obtained from the pain severity assessment tool. Having a regular menstrual cycle (21-35), duration of normal bleeding (3-7), and volume of normal bleeding according to the individual's statement, history, and examination by the therapist. 18 years 30 years Female Sumac allergy self-reported Pregnancy and childbirth history Medical conditions including thyroid disorders, diabetes, endometriosis, ovarian cysts, uterine fibroids, glandular disorders, polycystic ovary, primary or secondary amenorrhea, cancer, cardiovascular, kidney and liver, and urinary and genital infections, as stated by the individual and medical records, and examination by the therapist and ultrasound. History of surgery on the uterus and ovaries Undergoing infertility treatment Medication use of aspirin, warfarin, heparin, and tranexamic acid as reported by the individual and in the medical record N94 R53.83 Pain and other conditions associated with female genital organs and menstrual cycle Other fatigue Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: The first menstrual cycle received 250 mg mefenamic acid capsules, the second cycle received 1 gram sumac capsules, and in the third month received 1 gram sumac and 250 mg mefenamic acid capsules. It should be noted that the duration of the intervention will be the first three days of menstruation every 8 hours. Intervention group 2: In the first menstrual cycle, they will receive a capsule containing 1 gram of sumac, in the second cycle, a capsule containing 1 gram of sumac and a capsule containing 250 mg of mefenamic acid, and in the third month, a capsule containing 250 mg of mefenamic acid. It should be noted that the intervention period will be every 8 hours for the first three days of menstruation each month. Third intervention group: The first menstrual cycle, the recipient received 1 gram sumac capsules and 250 mg mefenamic acid capsules, the second cycle, the recipient received 250 mg mefenamic acid capsules and in the third month, 1 gram sumac capsules. It should be noted that the duration of the intervention will be the first three days of menstruation every 8 hours in each month. Pain score after receiving interventions. Timepoint: In three stages, pain scores are measured during the first three days of menstruation for each group. Method of measurement: To measure pain intensity, a standard 100 mm VAS tool, whose validity has been previously determined, will be used, and pain intensity will be measured using a graduated ruler, with a score of 10 representing the most severe pain and a score of 0 representing no pain. Fatigue score. Timepoint: In three stages, pain scores are measured during the first three days of menstruation for each group. Method of measurement: Multidimensional Fatigue Index (MFI). Mouse Menstrual Distress Questionnaire Score. Timepoint: It will be done every three months on the first three days of menstruation. Method of measurement: Mouse Questionnaire. Amount of menstrual bleeding. Timepoint: It will be done every three months on the first three days of menstruation. Method of measurement: Higham Chart or PBAC Blood Loss Assessment Chart. Energy received. Timepoint: It will be done every three months on the first three days of menstruation. Method of measurement: 24-hour recall questionnaire. Protein intake. Timepoint: It will be done every three months on the first three days of menstruation. Method of measurement: 24-hour recall questionnaire. Carbohydrate intake. Timepoint: It will be done every three months on the first three days of menstruation. Method of measurement: 24-hour recall questionnaire. Fat intake. Timepoint: It will be done every three months on the first three days of menstruation. Method of measurement: 24-hour recall questionnaire. Gonabad University of Medical Sciences Approved 2024-11-04 Ethics Committee of Gonabad University of Medical Sciences Dr. Mehdizadeh Boulevard Gonabad Razavi Khorasan Iran (Islamic Republic of)