Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
NCT ID: NCT07106996
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
90 participants
INTERVENTIONAL
2025-07-28
2026-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Accept the red yeast rice intervention group
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.
red yeast rice，RYR
Participants will take 6 grams of red yeast rice daily for 6 months.
Interventions
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red yeast rice，RYR
Participants will take 6 grams of red yeast rice daily for 6 months.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Lishui Hospital of Traditional Chinese Medicine
UNKNOWN
Sichuan Provincial People's Hospital
OTHER
Responsible Party
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Zhengwei Wan
professor
Locations
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Lishui Hospital of Traditional Chinese Medicine
Lishui, Zhejiang, China
Countries
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Facility Contacts
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Other Identifiers
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8240062474
Identifier Type: OTHER
Identifier Source: secondary_id
82401924
Identifier Type: -
Identifier Source: org_study_id
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