NCT07106996RecruitingEarly phase 1
Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
Source: ClinicalTrials.gov · Last updated 6 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 4 Jul 2025
- Start date
- 28 Jul 2025
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Sichuan Provincial People's Hospital
- NCT number
- NCT07106996
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 90
- From 28 Jul 2025 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Lab values
- Pregnant women (confirmed via urine/serum hCG)
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lishui Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Lishui | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.