Effects of a standardized saffron extract (Safr′Inside™) on menopause-related symptoms: a randomised, double-blind, placebo-controlled trial in perimenopausal women

Menopausal symptoms, which may emerge during perimenopause and include psychological, somatic, vasomotor, and sleep-related disturbances, can substantially impair women′s well-being and quality of life. Saffron (Crocus sativus L.) has emerged as a promising non-hormonal nutritional approach, with potential benefits for emotional wellbeing and stress-related symptoms. This study evaluated the efficacy and safety of Safr′Inside™, a standardized saffron extract, in perimenopausal women. This multicentre, randomized, double-blind, placebo-controlled trial enrolled 104 healthy perimenopausal women (mean age: 45.7 ± 3.7 years) receiving Safr′Inside™ (30 mg/day) or matched placebo for 12 weeks. Assessments were performed at baseline, 6 week, and 12 weeks. The primary outcome was change in menopausal symptom severity assessed using the Greene Climacteric Scale (GCS). Secondary outcomes included mood assessed using the Profile of Mood States (POMS), sleep quality using the Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life using the Short Form-36(SF-36). Metabolic, endocrine, and safety parameters were also assessed. At week 12, total GCS scores decreased significantly more with Safr′Inside™ than with placebo, with mean reductions of 68% and 17%, respectively (p<0.0001). Improvements were already evident at week 6 and were most pronounced for psychological and somatic symptoms, including anxiety and depression. Night sweats significantly improved, while the overall vasomotor score showed a favourable trend (p=0.06). Saffron also improved negative mood, selected sleep-related outcomes and several dimensions of quality of life. Safr′Inside™ significantly reduced overall perimenopausal symptom burden, with benefits across psychological, somatic, mood, sleep-related, and selected vasomotor outcomes. These findings support further investigation of standardized saffron extract as a non-hormonal nutritional approach for perimenopausal symptom management.