Polycystic Ovary Syndrome (PCOS)Early Phase 1NCT07106996
Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
A Early Phase 1 study testing red yeast rice，RYR in people with Polycystic Ovary Syndrome (PCOS), run by Sichuan Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- red yeast rice，RYR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2025to 1 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Lishui Hospital of Traditional Chinese Medicine
Lishui, Zhejiang, 323000
Zhengwei Wan, 18715799366, 18715799366@163.com
About this study
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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- red yeast rice，RYR
- Keywords
- Polycystic ovary syndrome, red yeast rice, intestinal microbiota, indole metabolism
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red yeast rice，RYRDrug
Participants will take 6 grams of red yeast rice daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Accept the red yeast rice intervention group | Experimental | Red yeast rice (RYR), a fermented product that has both medicinal and edible properties, is one of the traditional Chinese medicines used in the treatment of metabolic diseases. The main components of red yeast rice include monacolins, monacolin K, red yeast rice pigments, ergosterol, stigmasterol, β-sitosterol, daucosterol. Receives: Drug: red yeast rice，RYR |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory marker IL18 [pg/ml]
Measured: Baseline, the 3rd month and the 6th month after the intervention
inflammatory marker IL1β [pg/ml]
Measured: Baseline, the 3rd month and the 6th month after the intervention
testosterone (nmol/l)
Measured: Baseline, the 3rd month and the 6th month after the intervention
Follicle - Stimulating Hormone (mIU/mL)
Measured: Baseline, the 3rd month and the 6th month after the intervention
Luteinizing Hormone (mIU/mL)
Measured: Baseline, the 3rd month and the 6th month after the intervention
Estradiol (pmol/l)
Measured: Baseline, the 3rd month and the 6th month after the intervention
Progesterone (ng/mL)
Measured: Baseline, the 3rd month and the 6th month after the intervention
Prolactin (ng/mL)
Measured: Baseline, the 3rd month and the 6th month after the intervention
follicles number
The number of follicles in each ovary of each participant will be determined by ultrasonography.
Measured: Baseline, the 3rd month and the 6th month after the intervention
ovarian volume(Length x Width x Thickness/2,ml)
The size of each ovary in each participant will be determined by ultrasonography.
Measured: Baseline, the 3rd month and the 6th month after the intervention
Follicle diameter(mm)
The diameter of the follicles will be determined by ultrasonography.
Measured: Baseline, the 3rd month and the 6th month after the intervention
Hydroxyindole concentration
Measured: Baseline, the 3rd month and the 6th month after the intervention
Secondary outcomes (2)
Body-mass-index (BMI)
BMI measured with the formula BMI=weight [kg]/height² [m]
Measured: Baseline, the 3rd month and the 6th month after the intervention
waist-to-hip ratio
Calculated with the formula: waist circumference/hip circumference
Measured: Baseline, the 3rd month and the 6th month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start28 Jul 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lishui Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Zhengwei Wan, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106996
- Sponsor's protocol ID
- 82401924
- Other IDs
- 8240062474
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07106996
- Acronym / sponsor ID
- 82401924
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- Polycystic ovary syndrome, red yeast rice, intestinal microbiota, indole metabolism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Lishui Hospital of Traditional Chinese Medicine
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accept the red yeast rice intervention group | Experimental | Drug: red yeast rice，RYRRed yeast rice (RYR), a fermented product that has both medicinal and edible properties, is one of the traditional Chinese medicines used in the treatment of metabolic diseases. The main components of red yeast rice include monacolins, monacolin K, red yeast rice pigments, ergosterol, stigmasterol, β-sitosterol, daucosterol. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| red yeast rice，RYRParticipants will take 6 grams of red yeast rice daily for 6 months. | Drug | Accept the red yeast rice intervention group |
Primary outcome
inflammatory marker IL18 [pg/ml]
Time frame: Baseline, the 3rd month and the 6th month after the intervention
inflammatory marker IL1β [pg/ml]
Time frame: Baseline, the 3rd month and the 6th month after the intervention
testosterone (nmol/l)
Time frame: Baseline, the 3rd month and the 6th month after the intervention
Follicle - Stimulating Hormone (mIU/mL)
Time frame: Baseline, the 3rd month and the 6th month after the intervention
Luteinizing Hormone (mIU/mL)
Time frame: Baseline, the 3rd month and the 6th month after the intervention
Estradiol (pmol/l)
Time frame: Baseline, the 3rd month and the 6th month after the intervention
Progesterone (ng/mL)
Time frame: Baseline, the 3rd month and the 6th month after the intervention
Prolactin (ng/mL)
Time frame: Baseline, the 3rd month and the 6th month after the intervention
follicles number
Time frame: Baseline, the 3rd month and the 6th month after the intervention
The number of follicles in each ovary of each participant will be determined by ultrasonography.
ovarian volume(Length x Width x Thickness/2,ml)
Time frame: Baseline, the 3rd month and the 6th month after the intervention
The size of each ovary in each participant will be determined by ultrasonography.
Follicle diameter(mm)
Time frame: Baseline, the 3rd month and the 6th month after the intervention
The diameter of the follicles will be determined by ultrasonography.
Hydroxyindole concentration
Time frame: Baseline, the 3rd month and the 6th month after the intervention
2 secondary outcomes
Body-mass-index (BMI)
Time frame: Baseline, the 3rd month and the 6th month after the intervention
waist-to-hip ratio
Time frame: Baseline, the 3rd month and the 6th month after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing red yeast rice，RYR in people with Polycystic Ovary Syndrome (PCOS), run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory marker IL18 [pg/ml] (time frame: Baseline, the 3rd month and the 6th month after the intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.