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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorSichuan Provincial People's Hospital

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • red yeast rice,RYR

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Provincial People's Hospital

Lead sponsor

Lishui Hospital of Traditional Chinese Medicine

Collaborator