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Taking people in ChinaEarly phase 1

Testing red yeast rice for inflammation in polycystic ovary syndrome

Tests red yeast rice in women with polycystic ovary syndrome.

Plain-language title generated from the registry record
Registry title: Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome

Key facts

Where
Lishui, ChinaSee the site
Phase
Early phase 1

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18-40 with polycystic ovary syndrome (PCOS). Participants take red yeast rice for 6 months.

Age
18-40 years
Sex
Women only
Disease stage
PCOS meeting the Rotterdam criteria (at least two of: no or rare ovulation, signs of high androgen levels, polycystic ovaries on ultrasound).
Earlier treatment
No antibiotics or other drugs that can change gut bacteria (such as probiotics, prebiotics) within 3 months before joining.

Main reasons for not taking part

  • Pregnant women
  • Infectious diseases or severe dysfunction of multiple organs
  • Antibiotics or gut-flora-altering drugs (such as probiotics, prebiotics) within 3 months before joining

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 40 years old?

Source: NCT07106996, who can take part

Where in China

  • Lishui Hospital of Traditional Chinese MedicineLishui, ChinaContact: Zhengwei WanTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Sichuan Provincial People's Hospital
Trial code
NCT07106996
Record updated
6 August 2025
Original description
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.Read full original descriptionShow less

Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome

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.

Inclusion: 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: 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; Pregnant women (confirmed via urine/serum hCG).

ClinicalTrials.gov NCT07106996