Abstract

Background: Primary dysmenorrhea, a highly prevalent condition that significantly impacts women’s daily activities and quality of life, occurs without underlying pelvic pathological changes. Conventional treatments, such as warm water therapy, provide temporary relief; however, more effective interventions are needed. This study aimed to evaluate the effectiveness of an Adlay-based formula in reducing dysmenorrhea symptoms through randomized controlled trials. Methods: A total of 69 participants were randomly assigned to either the Adlay-based formula group (n = 35) or the placebo group (n = 34). Baseline characteristics, including age, age of menarche, dysmenorrhea onset, menstrual duration, BMI, blood pressure, and heart rate, were comparable between groups. The primary outcomes were measured using the Visual Analogue Scale (VAS) for dysmenorrhea, pain assessment scales, the Menstrual Distress Questionnaire (MDQ), and serum levels of inflammatory biomarkers (PGE2, PGF2α, IL-6, Hs-CRP). Results: The intervention group showed a significant reduction in VAS scores at both the first treatment and at the end of the study compared to baseline and the placebo group. Pain assessments indicated improvements in persistent pain, dull pain, exhaustion, nausea/vomiting, lower abdominal swelling, back pain, diarrhea, and cold sweats. Additionally, biomarker analysis revealed significant reductions in PGE2, PGF2α, and Hs-CRP levels in the intervention group, with no significant change in IL-6 levels. Conclusions: The Adlay-based formula effectively alleviated dysmenorrhea symptoms, improved pain and discomfort, and reduced inflammatory biomarkers compared to placebo. These findings suggested that the formula could serve as a promising alternative for managing primary dysmenorrhea.