Actively Recruiting
Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
Led by Sichuan Provincial People's Hospital · Updated on 2025-08-06
90
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
S
Sichuan Provincial People's Hospital
Lead Sponsor
L
Lishui Hospital of Traditional Chinese Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of red yeast rice on symptoms in women with polycystic ovary syndrome (PCOS). The study aims to understand how red yeast rice may improve PCOS symptoms and to explore the relationship between gut bacteria metabolism, specifically the indole pathway, and clinical signs of PCOS. The study is an early phase 1 clinical trial led by Sichuan Provincial People's Hospital. Participants will take 6 grams of red yeast rice daily for 6 months. The red yeast rice contains various components like monacolins and pigments thought to affect metabolic diseases. The study will monitor changes before treatment, at 3 months, and at 6 months, including clinical symptoms and biological samples from feces and blood to analyze gut microbiota metabolites. During the study, participants will have regular assessments measuring inflammation markers, sex hormones, ovarian follicle characteristics, and hydroxyindole levels. Body mass index and waist-to-hip ratio will also be tracked. These evaluations occur at baseline, 3 months, and 6 months post-intervention to monitor progress and safety throughout the study period, which lasts 6 months in total.
CONDITIONS
Brief Title
Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-40 years old
- Meet the Rotterdam criteria with at least two of the following: anovulation or oligo-ovulation, clinical evidence of hyperandrogenism or hyperandrogenemia, ultrasound showing polycystic ovarian morphology (minimum 12 follicles 2-9 mm or ovarian volume >10 mL in one ovary)
- Fully informed of study procedures and risks and voluntarily agree to participate
You will not qualify if you...
- Pregnant women confirmed by urine or serum hCG test
- Patients with infectious diseases or severe dysfunction of multiple systemic organs
- Patients who have taken antibiotics or drugs affecting intestinal flora composition (such as probiotics or prebiotics) within 3 months before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take 6 grams of red yeast rice daily to help improve chronic inflammation associated with polycystic ovary syndrome.
Visits at baseline, 3 months, and 6 months for assessments
Trial Site Locations
Total: 1 location
1
Lishui Hospital of Traditional Chinese Medicine
Lishui, Zhejiang, China, 323000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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