Actively Recruiting

Early Phase 1
Age: 18Years - 40Years
FEMALE
NCT07106996

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

Led by Sichuan Provincial People's Hospital · Updated on 2025-08-06

90

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

S

Sichuan Provincial People's Hospital

Lead Sponsor

L

Lishui Hospital of Traditional Chinese Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18-40 years old
  • Meeting the Rotterdam criteria with at least two of the following: anovulation or oligo-ovulation, clinical evidence of hyperandrogenism or hyperandrogenemia, ultrasound showing polycystic ovarian morphology
  • Fully informed about study procedures and risks and voluntarily agreeing to participate
Not Eligible

You will not qualify if you...

  • Pregnant women confirmed by urine or serum hCG test
  • Patients with infectious diseases or severe dysfunction of multiple systemic organs
  • Patients who have taken antibiotics or drugs affecting intestinal flora such as probiotics or prebiotics within 3 months before enrollment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Lishui Hospital of Traditional Chinese Medicine

Lishui, Zhejiang, China, 323000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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