Journal of Nutrition & Health
Research Article
Effects of a Standardized Saffron Extract on Premenstrual Symptoms: An Open-Label, Exploratory, Real-World Consumer Study
Emmanuelle Arnaud*, Ilona Gille, and Maïté Jeanroy
Activ’Inside, Beychac-et-Caillau, France
*Address for Correspondence:Emmanuelle Arnaud, Activ’Inside, Beychac-et-Caillau, France,
Email: e.arnaud@activinside.com
Submission: 14 April, 2026
Accepted: 05 May, 2026
Published: 08 May, 2026
Copyright: ©2026 Arnaud E, et al. This is an open access
article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is
properly cited.
Keywords:Premenstrual syndrome; Women’s health; Crocus sativus; Open study; Saffron extract
Abstract
Background: Premenstrual syndrome is a common cyclical condition characterized by emotional and physical symptoms that may affect daily functioning and quality of life. Because many women rely on analgesics to manage these symptoms, interest is growing in complementary approaches that may help support both psychological-related and physical complaints.
Objective: To assess the tolerability and perceived effects of a patented standardized saffron extract (Safr’Inside™) on premenstrual symptoms under real-life conditions.
Methods: An open-label, exploratory, real-world consumer study with medical oversight was conducted in California in women aged 20-45 years reporting recurrent premenstrual symptoms. Participants consumed one capsule containing 30 mg of a standardized saffron extract during a 10-day perimenstrual window over two consecutive cycles. PMS-related symptoms were assessed at baseline and after each supplemented cycle using an identical structured questionnaire (Q0, Q1 and Q2). The questionnaire captured 16 psychological and physical symptoms rated on a 0-10 Visual Analogue Scale (VAS), as well as treatment use, satisfaction, tolerability, and compliance.
Results: Across both supplemented cycles, Safr’Inside™ use was associated with self-reported improvements in emotional and physical symptoms. Participants reported improvements in both psychological-related outcomes (including quality of life impact, emotional imbalance, irritability, and nervousness) and physical symptoms (including appetite changes, digestive discomfort, physical fatigue, and water retention). Compliance was high and no adverse effects were reported.
Conclusions: In this open-label, exploratory, real-world consumer study, 10-day supplementation with a standardized saffron extract, administered 5 days before the onset of menstruation, was associated with self-reported improvements in both emotional and physical premenstrual symptoms under everyday conditions. These findings should be interpreted cautiously and considered as preliminary complementary real-world evidence.
Objective: To assess the tolerability and perceived effects of a patented standardized saffron extract (Safr’Inside™) on premenstrual symptoms under real-life conditions.
Methods: An open-label, exploratory, real-world consumer study with medical oversight was conducted in California in women aged 20-45 years reporting recurrent premenstrual symptoms. Participants consumed one capsule containing 30 mg of a standardized saffron extract during a 10-day perimenstrual window over two consecutive cycles. PMS-related symptoms were assessed at baseline and after each supplemented cycle using an identical structured questionnaire (Q0, Q1 and Q2). The questionnaire captured 16 psychological and physical symptoms rated on a 0-10 Visual Analogue Scale (VAS), as well as treatment use, satisfaction, tolerability, and compliance.
Results: Across both supplemented cycles, Safr’Inside™ use was associated with self-reported improvements in emotional and physical symptoms. Participants reported improvements in both psychological-related outcomes (including quality of life impact, emotional imbalance, irritability, and nervousness) and physical symptoms (including appetite changes, digestive discomfort, physical fatigue, and water retention). Compliance was high and no adverse effects were reported.
Conclusions: In this open-label, exploratory, real-world consumer study, 10-day supplementation with a standardized saffron extract, administered 5 days before the onset of menstruation, was associated with self-reported improvements in both emotional and physical premenstrual symptoms under everyday conditions. These findings should be interpreted cautiously and considered as preliminary complementary real-world evidence.
List of abbreviations:
EFSA: European Food Safety Authority; 5-HIAA:
5-Hydroxyindoleacetic Acid; PMDD: Premenstrual Dysphoric
Disorder; PMS: Premenstrual Syndrome; SERT: Serotonin
Transporter; SSRI: Selective Serotonin Reuptake Inhibitor; UHPLC:
Ultra-High-Performance Liquid Chromatography; UV: Ultraviolet;
VAS: Visual Analogue Scale.