NCT07106996 Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
| NCT ID | NCT07106996 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Sichuan Provincial People's Hospital |
| Condition | Polycystic Ovary Syndrome (PCOS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-07-28 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2025-07-28 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT07106996 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Polycystic Ovary Syndrome (PCOS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07106996 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07106996 currently recruiting?
Yes, NCT07106996 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sichuan Provincial People's Hospital to inquire about joining.
Where is the NCT07106996 trial being conducted?
This trial is being conducted at Lishui, China.
Who is sponsoring the NCT07106996 clinical trial?
NCT07106996 is sponsored by Sichuan Provincial People's Hospital. The trial plans to enroll 90 participants.