red yeast rice，RYR: Participants will take 6 grams of red yeast rice daily for 6 months.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
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
Primary outcome measure(s)
inflammatory marker IL18 [pg/ml] — Baseline, the 3rd month and the 6th month after the intervention
inflammatory marker IL1β [pg/ml] — Baseline, the 3rd month and the 6th month after the intervention
testosterone (nmol/l) — Baseline, the 3rd month and the 6th month after the intervention
Follicle - Stimulating Hormone (mIU/mL) — Baseline, the 3rd month and the 6th month after the intervention
Luteinizing Hormone (mIU/mL) — Baseline, the 3rd month and the 6th month after the intervention
Estradiol (pmol/l) — Baseline, the 3rd month and the 6th month after the intervention
Progesterone (ng/mL) — Baseline, the 3rd month and the 6th month after the intervention
Prolactin (ng/mL) — Baseline, the 3rd month and the 6th month after the intervention
follicles number — 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.
ovarian volume(Length x Width x Thickness/2,ml) — Baseline, the 3rd month and the 6th month after the intervention The size of each ovary in each participant will be determined by ultrasonography.
Follicle diameter(mm) — Baseline, the 3rd month and the 6th month after the intervention The diameter of the follicles will be determined by ultrasonography.
Hydroxyindole concentration — Baseline, the 3rd month and the 6th month after the intervention
Trial sites (1)
Facility
City
Region
Status
Lishui Hospital of Traditional Chinese Medicine
Lishui
Zhejiang
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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