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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Lishui Hospital of Traditional Chinese Medicine
RECRUITING
Lishui
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 90
Treatments
Experimental: Accept the red yeast rice intervention group
Red yeast rice (RYR), a fermented product that has both medicinal and edible properties, is one of the traditional Chinese medicines used in the treatment of metabolic diseases. The main components of red yeast rice include monacolins, monacolin K, red yeast rice pigments, ergosterol, stigmasterol, β-sitosterol, daucosterol.
Sponsors
Leads: Sichuan Provincial People's Hospital
Collaborators: Lishui Hospital of Traditional Chinese Medicine

This content was sourced from clinicaltrials.gov