Evaluating and comparing the efficacy of Fenugreek tablet and Mefnamic acid in the management of primary Dysmenorrhea, a randomized controlled trial

To compare the efficacy of fenugreek seed powder capsules with mefenamic acid in women aged 18–35 years with primary dysmenorrhea by evaluating menstrual pain intensity, onset and duration of treatment effect, menstrual blood loss, gastrointestinal symptoms, PANAS and IPAQ scores, and the efficacy and safety of fenugreek as an alternative or complementary treatment

A phase II, randomized, double-blind, parallel-group, controlled clinical trial will be conducted in 80 patients with primary dysmenorrhea (40 participants per group). participants will be allocated to the fenugreek and mefenamic acid groups using permuted block randomization with 10 blocks of 8 participants.

conducted at Imam Ali Clinic in Shahrekord, Iran, among women aged 18–35 years with primary dysmenorrhea. participants randomly allocated to the groups and followed for two consecutive menstrual cycles. A double-blind; identical capsules coded and prepared by an independent person.

Women aged 18–35 years. Confirmed diagnosis of primary dysmenorrhea Regular menstrual cycles (21–35 days). Moderate to severe menstrual pain Willingness to participate and provision of written informed consent. No known allergy to fenugreek or mefenamic acid. No significant systemic diseases No secondary causes of dysmenorrhea washout period before enrollment.

Intervention group (Fenugreek): receiving 335 mg fenugreek seed powder capsule three times daily from the first to the third day of menstruation Control group (Mefenamic acid): receiving one 250 mg mefenamic acid capsule three times daily from the first to the third day of menstruation. Capsules dentical in appearance, trial conducted under a double-blind design

Menstural pain intensity Duration of analgesic effect Time to onset of analgesic effect Menstural blood loss

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.

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.

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