Effects of a standardized saffron extract (Safr'Inside™) on menopause-related symptoms: a randomised, double-blind, placebo-controlled trial in perimenopausal women
- 1ActivInside, Beychac et Caillau, France
Abstract
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. Trial Registration ClinicalTrials.gov ID: NCT06227858
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BibTeX
@misc{sultana2026effects,
title = {{Effects of a standardized saffron extract (Safr'Inside™) on menopause-related symptoms: a randomised, double-blind, placebo-controlled trial in perimenopausal women}},
author = {R. Sultana and H. Amjad and H. Zafar and M. Maqsood and S. Ullah Mumtaz and Q.-u. Ain and R. Jamil and A. Ghulam and S. Jabeen and S. Farooq and F. Afridi and I. Ujjan and H. Khalid and C. Pouchieu and L. Pourtau and D. Gaudout and B. Moras and L. Lang and D. Vauzour and A. Khan},
howpublished = {medRxiv},
year = {2026},
month = oct,
doi = {10.64898/2026.10.12.26365297},
url = {https://www.medrxiv.org/content/10.64898/2026.10.12.26365297v1},
note = {Public domain},
}
RIS
TY - UNPB
TI - Effects of a standardized saffron extract (Safr'Inside™) on menopause-related symptoms: a randomised, double-blind, placebo-controlled trial in perimenopausal women
AU - R. Sultana
AU - H. Amjad
AU - H. Zafar
AU - M. Maqsood
AU - S. Ullah Mumtaz
AU - Q.-u. Ain
AU - R. Jamil
AU - A. Ghulam
AU - S. Jabeen
AU - S. Farooq
AU - F. Afridi
AU - I. Ujjan
AU - H. Khalid
AU - C. Pouchieu
AU - L. Pourtau
AU - D. Gaudout
AU - B. Moras
AU - L. Lang
AU - D. Vauzour
AU - A. Khan
PY - 2026
DA - 2026/10/12
PB - medRxiv
DO - 10.64898/2026.10.12.26365297
UR - https://www.medrxiv.org/content/10.64898/2026.10.12.26365297v1
AB - 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. Trial Registration ClinicalTrials.gov ID: NCT06227858
ER -