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Recruiting NCT07106996

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

Early Phase I Interventional Polycystic Ovary Syndrome (PCOS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: red yeast rice，RYR.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome (PCOS). Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug red yeast rice，RYR
    Participants will take 6 grams of red yeast rice daily for 6 months.

Primary outcome measures

  • inflammatory marker IL18 [pg/ml] [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
  • inflammatory marker IL1β [pg/ml] [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
  • testosterone (nmol/l) [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
  • Follicle - Stimulating Hormone (mIU/mL) [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
  • Luteinizing Hormone (mIU/mL) [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
  • Estradiol (pmol/l) [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
  • Progesterone (ng/mL) [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
  • Prolactin (ng/mL) [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
  • follicles number [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
  • ovarian volume(Length x Width x Thickness/2,ml) [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
Secondary outcome measures (2)
  • Body-mass-index (BMI) [Time frame: Baseline, the 3rd month and the 6th month after the intervention]
  • waist-to-hip ratio [Time frame: Baseline, the 3rd month and the 6th month after the intervention]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Lishui Hospital of Traditional Chinese Medicine — Lishui

Identifiers

NCT: NCT07106996 · 82401924 · 8240062474

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗