Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
Recruiting · NCT07106996 · Interventional (participants receive a specific treatment) · Lead sponsor: Sichuan Provincial People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- Lishui Hospital of Traditional Chinese Medicine - Lishui, Zhejiang, China