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

NCT07106996 | Recruiting Early Phase 1

• 2 other identifiers: 824019248240062474
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

Polycystic ovary syndrome; red yeast rice; intestinal microbiota; indole metabolism

Outcome Measures

Primary Outcomes (12)

• inflammatory marker IL18 [pg/ml]

  Baseline, the 3rd month and the 6th month after the intervention

• inflammatory marker IL1β [pg/ml]

  Baseline, the 3rd month and the 6th month after the intervention

• testosterone (nmol/l)

  Baseline, the 3rd month and the 6th month after the intervention

• Follicle - Stimulating Hormone (mIU/mL)

  Baseline, the 3rd month and the 6th month after the intervention

• Luteinizing Hormone (mIU/mL)

  Baseline, the 3rd month and the 6th month after the intervention

• Estradiol (pmol/l)

  Baseline, the 3rd month and the 6th month after the intervention

• Progesterone (ng/mL)

  Baseline, the 3rd month and the 6th month after the intervention

• Prolactin (ng/mL)

  Baseline, the 3rd month and the 6th month after the intervention

• follicles number

  The number of follicles in each ovary of each participant will be determined by ultrasonography.

  Baseline, the 3rd month and the 6th month after the intervention

• ovarian volume(Length x Width x Thickness/2,ml)

  The size of each ovary in each participant will be determined by ultrasonography.

  Baseline, the 3rd month and the 6th month after the intervention

• Follicle diameter(mm)

  The diameter of the follicles will be determined by ultrasonography.

  Baseline, the 3rd month and the 6th month after the intervention

• Hydroxyindole concentration

  Baseline, the 3rd month and the 6th month after the intervention

Secondary Outcomes (2)

• Body-mass-index (BMI)

  Baseline, the 3rd month and the 6th month after the intervention

• waist-to-hip ratio

  Baseline, the 3rd month and the 6th month after the intervention

Other Outcomes (2)

• The metagenomics of fecal samples

  before the intervention, at the 3rd month and the 6th month after the intervention

• Non-targeted metabolomic analysis of fecal and serum samples

  before the intervention, at the 3rd month and the 6th month after the intervention

Study Arms (1)

Accept the red yeast rice intervention group

EXPERIMENTAL

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.

Drug: red yeast rice，RYR

Interventions

red yeast rice，RYR DRUG

Participants will take 6 grams of red yeast rice daily for 6 months.

Accept the red yeast rice intervention group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead
• Lishui Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Lishui Hospital of Traditional Chinese Medicine

Lishui, Zhejiang, 323000, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: August 6, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

CN (1)