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IRCT20260629070010N1 IRCT 2026-08-28 Shahre-kord University of Medical Sciences Comparing Fenugreek tablet and Mefnamic acid in primary Dysmenorrhea Evaluating and comparing the efficacy of Fenugreek tablet and Mefnamic acid in the management of primary Dysmenorrhea, a randomized controlled trial 2026-01-07 anticipated 40 Recruiting https://irct.ir/trial/91365 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: Randomization is carried out using a block randomization method. Participants are assigned to either the intervention or control group via the "Random Allocation" software, employing a permuted block randomization approach. A randomization list comprising ten blocks of eight participants each will be prepared and entrusted to an individual who is blinded to the intervention details and group assignments. Participants are allocated to these ten blocks of eight based on the timing of their enrollment, ensuring that each block contains four participants in the intervention group and four in the control group. This arrangement ensures that participants within each block enter the study and progress through follow-up stages at similar times, while maintaining a balanced group size throughout the study. Allocation concealment is employed to prevent allocation bias. A randomization list is prepared and entrusted to an independent individual who is unaware of the nature of the interventions or the group assignments. The researcher responsible for enrolling participants has no access to this list and remains unaware of the specific treatment assigned to each group. Following the assessment of eligibility criteria and the acquisition of informed consent, each participant's group assignment is determined by the independent individual and communicated to the researcher. This process eliminates the possibility of predicting or manipulating assignments prior to enrollment, thereby preserving the study's internal validity, Blinding description: Allocation concealment is employed to prevent allocation bias. A randomization list is prepared and entrusted to an independent individual who is unaware of the nature of the interventions or the group assignments. The researcher responsible for enrolling participants has no access to this list and remains unaware of the specific treatment assigned to each group. Following the assessment of eligibility criteria and the acquisition of informed consent, each participant's group assignment is determined by the independent individual and communicated to the researcher. This process eliminates the possibility of predicting or manipulating assignments prior to enrollment, thereby preserving the study's internal validity. Both types of medication are prepared as capsules with identical packaging and appearance to ensure a double-blind study design (meaning neither the participants nor the researchers will know which medication is being administered). The capsules will be coded by an individual uninvolved in data collection or analysis (such as a pharmacist) and packaged in containers labeled only as "A" and "B," without identifying names. Neither the researchers nor the participants will be informed of the medication contents or participant group assignments until the data analysis is complete. Consequently, participants, the principal investigator, attending physicians, clinical care staff, researchers, and those involved in data collection and manuscript preparation will remain unaware of the medication contents and the composition of the intervention and control groups. 3 Condition 1: Primary dysmenorrhea. Condition 2: Primary dysmenorrhea. Intervention 1: Intervention group: Participants will receive one oral capsule containing 335 mg of fenugreek (Trigonella foenum-graecum) seed powder three times daily (every 8 hours) from the first to the third day of menstruation. The capsules are manufactured by Barij Essence Pharmaceutical Company and are identical in appearance and packaging to the control capsules. Intervention 2: Control group: Participants will receive one oral capsule containing 250 mg of mefenamic acid three times daily (every 8 hours) from the first to the third day of menstruation. The control capsules are identical in appearance and packaging to the intervention capsules to maintain blinding. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Shirin moazzan
Shariati Street, opposite the Tax Administration, Shahrekord, Chaharmahal and Bakhtiari Province
Shahre_kord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 913 381 0365 Shirinmd1984@gmail.com Shahre-kord University of Medical Sciences scientific Shirin Moazan
Shariati Street, opposite the Tax Administration, Shahrekord
Shahre_kord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 38 3224 2875 Shirinmd1984@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) 18 to 35 women Definitive diagnosis of primary dysmenorrhea (based on confirmation by a gynecologist and clinical history) Moderate to severe menstrual pain intensity (VAS score of 4 or higher or similar instrument) Consent to participate in the study and take the medication according to the physician's instructions. 18 years 35 years Female Absence of ASA Class 1 and 2 diseases Absence of a history of allergy to fenugreek and mefenamic acid, based on participant self-reporting. Absence of any secondary cause for menstrual pain, such as endometriosis, uterine fibroids, or the use of an intrauterine device (IUD). Avoidance of painkillers or similar herbal medications during the treatment period. Not regularly taking hormonal medications, oral contraceptives, or other chronic medications that could interfere with the study results. No history of severe drug allergy Absence of a history of mental illness Not intending to become pregnant while breastfeeding or using contraceptives. N94.4 N94.4 Primary dysmenorrhea Primary dysmenorrhea Treatment - Drugs Treatment - Drugs Intervention group: Participants will receive one oral capsule containing 335 mg of fenugreek (Trigonella foenum-graecum) seed powder three times daily (every 8 hours) from the first to the third day of menstruation. The capsules are manufactured by Barij Essence Pharmaceutical Company and are identical in appearance and packaging to the control capsules. Control group: Participants will receive one oral capsule containing 250 mg of mefenamic acid three times daily (every 8 hours) from the first to the third day of menstruation. The control capsules are identical in appearance and packaging to the intervention capsules to maintain blinding. Menstrual pain intensity measured using the 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Timepoint: Before intervention, 1, 2, and 4 hours after the first intervention, and on the second and third days of intervention. Method of measurement: Visual analog scale (VAS). Gastrointestinal symptoms assessed using a researcher-made checklist. Timepoint: At the end of each menstrual cycle (Cycle 1 and Cycle 2). Method of measurement: Researcher_made checklist. Duration of analgesic effect (h). Timepoint: 1, 2, and 4 hours after the first dose; Days 2 and 3 of treatment. Method of measurement: Researcher_made checklist. Time to onset of analgesic effect. Timepoint: 1, 2, and 4 hours after the first dose; Days 2 and 3 of treatment. Method of measurement: Researcher_made checklist. Menstrual blood loss measured using the Pictorial Blood Loss Assessment Chart (PBAC). Timepoint: At the end of each menstrual cycle (Cycle 1 and Cycle 2). Method of measurement: Pictorial Blood Loss Assessment Chart (PBAC). Mood status. Timepoint: Before the intervention and at the end of the second menstrual cycle. Method of measurement: Positive and Negative Affect Schedule (PANAS). Physical activity. Timepoint: Before the intervention and at the end of the second menstrual cycle. Method of measurement: International Physical Activity Questionnaire (IPAQ). Shahre-kord University of Medical Sciences Approved 2026-01-07 Research ethnic committee of Shahrekord University of Medical Science Parastar, past Kashani 43, Hajar Hospital and Maternity Center شهرکرد Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)