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

Sichuan Provincial People's Hospital

Status and phase: Enrolling; Early Phase 1

Conditions: Polycystic Ovary Syndrome (PCOS)

Treatments: Drug: red yeast rice，RYR

Study type: Interventional

Funder types: Other

Identifiers

NCT07106996

8240062474 (Other Identifier)

82401924

Details and patient eligibility

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Accept the red yeast rice intervention group

Experimental group

Description:

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.

Treatment:

Drug: red yeast rice，RYR