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NCT Number: NCT07106996

Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome

The aim of this study is to elucidate the effects of red yeast rice on the improvement of symptoms in patients with polycystic ovary syndrome（PCOS）, and to analyze the dose-response relationship between intestinal microbiota and its metabolite, hydroxyindole, and clinical indicators of PCOS.

The main questions it aims to answer are:

How effective is red yeast rice in treating PCOS? Does the indole metabolic pathway of gut microbiota play a crucial role in the improvement of PCOS symptoms by red yeast rice? Participants will take 6 grams of red yeast rice daily for 6 months, and records will be kept of their PCOS clinical symptoms and indicators before the intervention, at the 3rd month post-intervention, and at the 6th month post-intervention. Additionally, biological samples from feces and serum will be collected at these time points.

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Lishui Hospital of Traditional Chinese Medicine

Lishui, Zhejiang, 323000, China

Location status: Recruiting

Location contact

Zhengwei Wan

CONTACT

[email protected]

18715799366

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients aged 18-40 years old
  • Meeting the Rotterdam criteria (at least two of the following):
  • Anovulation or oligo-ovulation
  • Clinical evidence of hyperandrogenism or hyperandrogenemia
  • Ultrasound findings indicating polycystic ovarian morphology (defined as at least 12 follicles measuring 2-9 mm in diameter and/or an ovarian volume >10 mL [length × width × thickness / 2] in one ovary)
  • Subjects who have been fully informed of the study procedures and related risks, and voluntarily agree to participate

Exclusion criteria

  • Pregnant women (confirmed via urine/serum hCG)
  • Patients with concomitant infectious diseases or severe dysfunction of multiple systemic organs
  • Patients who have taken antibiotics or other drugs (such as probiotics, prebiotics, etc.) that can alter the composition of intestinal flora within 3 months before enrollment

Treatment and study plan

red yeast rice，RYR

Drug

Participants will take 6 grams of red yeast rice daily for 6 months.

Primary outcomes

  1. inflammatory marker IL18 [pg/ml]

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

  2. inflammatory marker IL1β [pg/ml]

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

  3. testosterone (nmol/l)

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

  4. Follicle - Stimulating Hormone (mIU/mL)

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

  5. Luteinizing Hormone (mIU/mL)

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

  6. Estradiol (pmol/l)

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

  7. Progesterone (ng/mL)

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

  8. Prolactin (ng/mL)

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

  9. follicles number

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

    The number of follicles in each ovary of each participant will be determined by ultrasonography.

  10. ovarian volume(Length x Width x Thickness/2,ml)

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

    The size of each ovary in each participant will be determined by ultrasonography.

  11. Follicle diameter(mm)

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

    The diameter of the follicles will be determined by ultrasonography.

  12. Hydroxyindole concentration

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

Secondary outcomes

  1. Body-mass-index (BMI)

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

    BMI measured with the formula BMI=weight [kg]/height² [m]

  2. waist-to-hip ratio

    Time frame: Baseline, the 3rd month and the 6th month after the intervention

    Calculated with the formula: waist circumference/hip circumference

Other outcomes

  1. The metagenomics of fecal samples

    Time frame: before the intervention, at the 3rd month and the 6th month after the intervention

    Total DNA of fecal samples is extracted by CTAB method.

  2. Non-targeted metabolomic analysis of fecal and serum samples

    Time frame: before the intervention, at the 3rd month and the 6th month after the intervention

    Fecal and serum samples were subjected to untargeted metabolomic detection using LC-MS/MS with an Agilent UHPLC system coupled to an Agilent 6538 UHD and Accurate-Mass Q-TOF mass spectrometer. Metabolites in the samples were separated, identified, and their information was acquired. Univariate and multivariate analyses were performed on the metabolites to screen for significantly differential metabolites before and after treatment.

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Collaborators

  • Lishui Hospital of Traditional Chinese Medicine

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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