Effect of Menstrugole capsule and Zintoma capsule versus Mefenamic Acid capsule on postpartum pains in multiparous women: a double-blind randomized clinical trial

To assess the effect of Menstrugole capsule and Zintoma capsule versus Mefenamic Acid capsule on postpartum pains in multiparous women

This is a Phase III double-blind randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.

This study will be conducted at the Atieh Hospital in Hamadan city, involving 135 multiparous women. The patients will be randomly assigned to the intervention groups including Menstrugole capsule and Zintoma capsule and control group including Mefenamic Acid capsule through the block randomization. This trial will be double -blinded.

Inclusion criteria: Age 15 to 44 years Second pregnancy and beyond Singleton vaginal delivery 37 to 42 weeks gestation Birth weight between 2500 and 4000 grams Exclusion criteria: Rapture grade 3 to 4 Previous cesarean section or abdominal surgery Use of epidural or spinal anesthesia during labor

Intervention group 1: Menstrugel capsule (containing dried celery, saffron, anise extract powder) 80 mg, manufactured by Gol Daru Company, 2 hours after delivery, every 6 hours, 4 capsules for up to 24 hours Intervention group 2: Zintoma capsule (containing ginger) 250 mg, manufactured by Gol Daru Company, 2 hours after delivery, every 6 hours, 4 capsules for up to 24 hours Control group: Mefenamic acid capsule 250 mg, 2 hours after delivery, every 6 hours, 4 capsules for up to 24 hours

Primary outcome: Average postpartum pain score

In this study, random assignment of patients to the intervention and control groups will be performed using block randomization. To achieve this, six sheets of paper will be prepared - two with the name of "Intervention 1," two with the name of "Intervention 2," and two with the name of "Control." These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.

Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as adouble -blind study.