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.
Female patients aged 18-40 years old
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)
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
Single group
red yeast rice，RYR
DrugParticipants will take 6 grams of red yeast rice daily for 6 months.
inflammatory marker IL18 [pg/ml]
inflammatory marker IL1β [pg/ml]
testosterone (nmol/l)
Follicle - Stimulating Hormone (mIU/mL)
Body-mass-index (BMI)
BMI measured with the formula BMI=weight \[kg\]/height² \[m\]
waist-to-hip ratio
Calculated with the formula: waist circumference/hip circumference
The metagenomics of fecal samples
Total DNA of fecal samples is extracted by CTAB method.
Non-targeted metabolomic analysis of fecal and serum samples
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.
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Sichuan Provincial People's Hospital
Lead sponsor
Lishui Hospital of Traditional Chinese Medicine
Collaborator
