Efficacy of a Standardized Ginger Extract for Menstrual Pain and Associated Symptoms in Women With Primary Dysmenorrhea: A Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Primary dysmenorrhea, a common gynecological condition characterized by painful menstrual cramps, significantly impairs quality of life. Ginger has traditionally been used for pain relief and is proposed to exert anti-inflammatory and analgesic effects. This study aimed to evaluate the efficacy and safety of a standardized ginger extract compared with placebo in women with primary dysmenorrhea. METHODS: In this randomized, double-blind, placebo-controlled, multicenter clinical study, participants with primary dysmenorrhea received either a standardized ginger extract or placebo twice daily for 90 days. The primary endpoints were changes in pain severity, assessed using the Visual Analog Scale (VAS), and dysmenorrhea severity, assessed using the Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) score. Secondary endpoints included changes in menstrual symptom burden, assessed using the Menstrual Distress Questionnaire (MEDI-Q), menstrual fluid flow, and global assessments. Exploratory endpoints included prostaglandin F2α (PGF2α) levels. Efficacy analyses were performed in the intention-to-treat (ITT) and per-protocol (PP) populations. RESULTS: Compared with placebo (n = 47), standardized ginger extract (n = 49) significantly reduced pain severity and overall dysmenorrhea severity from Cycle 1 onward. At Cycle 3, VAS and WaLIDD scores were reduced by 31.2%-33.3% and 62.4%-63.5%, respectively, from baseline (p < 0.001). Significant improvements in menstrual symptom burden and menstrual fluid flow (31.9% reduction) were observed compared with placebo (p < 0.05 to p < 0.001). PGF2α levels decreased significantly by 11.6%-11.9% in the ginger extract group, whereas they increased in the placebo group (p < 0.001). The intervention was well tolerated, with no clinically significant adverse events reported. CONCLUSION: Standardized ginger extract significantly reduced pain severity, dysmenorrhea severity, menstrual symptom burden, and menstrual fluid flow in women with primary dysmenorrhea. Its favorable safety and tolerability profile support its potential utility as a non-hormonal therapeutic approach for the management of primary dysmenorrhea.