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New treatment option for Polycystic Ovary Syndrome (PCOS)
Official title Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT07106996
What this study is testing
What is red yeast rice，RYR?
red yeast rice，RYR is an investigational medicine, given as an once-daily, being studied as a potential treatment for polycystic ovary syndrome (pcos).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- 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...
You likely can't join if
- 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...
See the full eligibility 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)
- people who have been fully informed of the study procedures and related risks, and voluntarily agree to participate
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lishui, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lishui, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.