Randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the efficacy of a nutraceutical containing Cinchona bark, Chicory root, Gentian root, Griffonia simplicifolia and Vitex agnus-castus in women with premenstrual syndrome
Premenstrual syndrome in women of reproductive age
Participants were assigned through 1:1 randomization using a computer-generated randomization list to receive either Agrigenina® or a placebo. Agrigenina® was administered as gastro-resistant capsules containing a multicomponent nutraceutical formulation composed of 200 mg of Cinchona succirubra bark extract, 100 mg of Gentiana lutea root extract, 100 mg of Cichorium intybus root extract, 100 mg of Griffonia simplicifolia extract, and 25 mg of Vitex agnus-castus extract. The supplement was taken as two capsules per day, administered twice daily approximately 1 hour before meals during the premenstrual and/or menstrual phase. The placebo consisted of maltodextrins and was identical in appearance, color, and smell to the active formulation. The study lasted 6 months and included a 2-month run-in period, followed by 3 months of treatment with Agrigenina® or placebo and a 1-month follow-up period after supplementation discontinuation. The Premenstrual Symptoms Screening Tool (PSST) questionnaire was completed at the end of each menstrual cycle throughout the study period, allowing monthly assessment of hunger perception, PMS symptom severity, and their impact on quality of life.
1. Women aged 18–46 years 2. Presence of premenstrual syndrome defined as recurrent somatic, psychological, or behavioral symptoms occurring during the premenstrual and/or menstrual phase in at least four of the previous six menstrual cycles, including the most recent one 3. Regular menstrual cycle 4. Willingness to maintain usual dietary habits and physical activity levels throughout the study period
1. History of chronic diseases such as coagulopathies, diabetes, cardiovascular or renal disorders 2. Cigarette smoking or alcohol consumption 3. Use of nutritional supplements or hormonal medications during the study period 4. Allergy or hypersensitivity to dietary supplements or study product components 5. Irregular menstruation 6. Pregnancy or breastfeeding 7. History of psychological or psychiatric disorders 8. Stressful events occurring in the three months prior to the beginning of the study that could represent a confounding factor