{
  "abstract": "BackgroundPremenstrual syndrome (PMS) affects nearly half of women of reproductive age and can substantially impair quality of life, daily functioning, and psychological well-being. Although saffron extract has been proposed as a potential non-pharmacological approach for PMS management, clinical evidence remains limited. This randomized, multicentric, double-blind, placebo-controlled trial evaluated the efficacy and tolerability of saffron extract in reducing PMS symptoms.\n\nMethodsA total of 110 healthy women aged 18-45 years with mild-to-moderate PMS were randomized to receive saffron extract (30 mg/day; SafrInsideTM) or placebo for three menstrual cycles. The primary endpoint was the Premenstrual Assessment Form-Short Form (PAF-SF) total score. Secondary endpoints included PAF-SF affect, pain, and water retention subscales, and the Patient Health Questionnaire-4 (PHQ-4) total score. Efficacy analyses were performed in the intention-to-treat (ITT) and per-protocol populations using linear mixed-effects models.\n\nResultsSaffron supplementation resulted in a significantly greater reduction in overall PMS symptoms than the placebo (difference in slope for PAF-SF total score: -1.88; 95% confidence interval [CI] -2.64 to -1.12; p<0.001). Between-group differences in change from baseline were significant at 7 days (-2.42; 95% CI -4.79 to -0.04; p=0.046), 35 days (-3.40; 95% CI -5.78 to -1.02; p=0.010), and 63 days of supplementation (-5.96; 95% CI -8.34 to -3.58; p<0.001). Significant improvements were also observed for affective symptoms (p=0.003), pain (p<0.001), water retention (p<0.001) from the PAF-SF, and psychological distress as assessed by the PHQ-4 total score (p=0.011). No adverse events were reported.\n\nConclusionsDaily supplementation with saffron extract over three menstrual cycles significantly improved overall PMS symptom severity compared with placebo in women with mild-to-moderate PMS. Benefits were also observed for affective, pain, and water retention symptoms. Saffron extract was well-tolerated and may represent a promising non-pharmacological option for women experiencing bothersome PMS symptoms.\n\nTrial registrationNCT07013539, date of registration 02/06/2025",
  "abstract_shown": true,
  "affiliations": [
    "Activ'Inside, 33750 Beychac et Caillau, France"
  ],
  "article_type": "PUBLISHAHEADOFPRINT",
  "arxiv": null,
  "author_total": 6,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "C. Pouchieu"
    },
    {
      "name": "R. Villa"
    },
    {
      "name": "F. Amone"
    },
    {
      "name": "L. Pourtau"
    },
    {
      "name": "B. Moras"
    },
    {
      "name": "V. Nobile"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/d1qf202rm7sz2.bib",
  "cited_by": 0,
  "doi": "10.64898/2026.10.19.26365879",
  "fulltext_url": "https://www.medrxiv.org/content/10.64898/2026.10.19.26365879v1.full",
  "id": "d1qf202rm7sz2",
  "issns": [],
  "landing_url": "https://www.medrxiv.org/content/10.64898/2026.10.19.26365879v1",
  "language": null,
  "licence": "CC-BY-ND",
  "licence_label": "CC BY-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "medrxiv",
      "nutrition"
    ],
    [
      "openalex",
      "2730|Saffron Plant Research Studies"
    ]
  ],
  "openalex": "W7223238732",
  "pdf_url": "https://www.medrxiv.org/content/10.64898/2026.10.19.26365879v1.full.pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-19",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/d1qf202rm7sz2.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:21:28Z",
      "native_id": "10.64898/2026.10.19.26365879",
      "source": "medrxiv",
      "url": "https://www.medrxiv.org/content/10.64898/2026.10.19.26365879v1"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "medrxiv:nutrition",
      "subfield": "nutrition"
    }
  ],
  "title": "Beneficial effects of a standardised saffron extract (SafrInside™) on premenstrual syndrome: a multicentric, double-blind, randomized, placebo-controlled trial",
  "title_text": "Beneficial effects of a standardised saffron extract (SafrInside™) on premenstrual syndrome: a multicentric, double-blind, randomized, placebo-controlled trial",
  "type": "preprint",
  "updated_at": "2026-10-30T12:21:28Z",
  "url": "https://research.draconitic.com/paper/d1qf202rm7sz2",
  "venue": "medRxiv",
  "versions": []
}