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. 2025 Aug 8;11(1):69.
doi: 10.1186/s40780-025-00432-7.

Evaluation of therapeutic effects of Crocin in patients with polycystic ovary syndrome: A randomized Double-Blind clinical trial

Fatemeh Saghafi  1 , Atiyeh Javaheri  2 , Farhad Mohammadi  3 , Nooshin Hatamizadeh  2 , Fatemeh Khanizadeh  4 , Mahdieh Safakish  5 , Adeleh Sahebnasagh  6
Affiliations

Evaluation of therapeutic effects of Crocin in patients with polycystic ovary syndrome: A randomized Double-Blind clinical trial

Fatemeh Saghafi et al. J Pharm Health Care Sci. .

Abstract

Background: Polycystic ovary syndrome (PCOS) is the most common endocrine-metabolic disorder in women of reproductive age. Crocin is known as the main component of saffron, which has antioxidant properties and has the ability to scavenge free radicals. Considering the pathophysiology of PCOS and also the anti-inflammatory and antioxidant properties of crocin in improving insulin resistance, we aimed to evaluate the efficacy of the combination of crocin and metformin compared to metformin alone in PCOS patients.

Methods: This study is a prospective, double-blind randomized controlled clinical trial. Fifty patients with PCOS and hirsutism were included from Baqaipour Obstetrics and Gynecology Clinic in Yazd and randomly assigned into the two study arms of control group [metformin and placebo (n = 25)] or intervention group [metformin and crocin (n = 25)]. Patients were administered crocin 15 mg tablets once a day in combination with metformin 500 mg twice a day for 12 weeks to complete three full periods of the monthly cycle. The studied endpoints were evaluated at the beginning and end of the study.

Results: Crocin significantly improved the serum level of follicle-stimulating hormone (FSH) (P = 0.048) and Ferriman- Gallwey score (P = 0.042) at day 90. Furthermore, crocin group had a significant improvement in terms of acne severity at the end of the study (P = 0.03), so that none of the patients in the crocin group had severe acne at the end of the study. However, the comparisons between two groups were not statistically significant for other evaluated outcomes including fasting blood sugar (FBS), dihydroepiandrosterone-sulfate (DHEA-S), luteinizing hormone (LH), dermatology life quality index (DLQI), and blood pressure (BP) at the end of the study.

Conclusion: In the present study, concurrent use of crocin along with metformin was significantly effective in ameliorating the unpleasant side effects of PCOS, including hirsutism and acne, and increasing FSH sex hormone levels in patients with PCOS.

Trial registry date: 26/08/2021, Trial Registry number: IRCT20210730052027N1.

Keywords: Acne; Crocin; Metformin; Polycystic ovary syndrome.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Study protocols were approved by the local Ethics Committee of Shahid Sadoughi University of Medical Sciences (Ethics ID: IR.SSU.MEDICINE.REC.1399.220). Following a health-screening questionnaire, all volunteers provided a written informed consent. Before the intervention, study protocol, benefits, and possible side effects were described for patients. Understandable written informed consent was obtained for all patients prior to participation in the study. This trial was performed in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines. Consent for publication: Consent for publication was agreed upon in the written consent forms signed by all subjects for publication of identifying information/images in a publication. Competing interests: The authors declare that they have no competing interests regarding the publication of this paper.

Figures

Fig. 1
Fig. 1
Flow diagram of participant’s recruitment and follow-up
See this image and copyright information in PMC

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