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

Обзор

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.

Вмешательства

• Препарат red yeast rice，RYR
  Participants will take 6 grams of red yeast rice daily for 6 months.

Первичные конечные точки

• inflammatory marker IL18 [pg/ml] [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]
• inflammatory marker IL1β [pg/ml] [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]
• testosterone (nmol/l) [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]
• Follicle - Stimulating Hormone (mIU/mL) [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]
• Luteinizing Hormone (mIU/mL) [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]
• Estradiol (pmol/l) [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]
• Progesterone (ng/mL) [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]
• Prolactin (ng/mL) [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]
• follicles number [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]
• ovarian volume(Length x Width x Thickness/2,ml) [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]

Вторичные конечные точки (2)

• Body-mass-index (BMI) [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]
• waist-to-hip ratio [Срок оценки: Baseline, the 3rd month and the 6th month after the intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Lishui Hospital of Traditional Chinese Medicine — Lishui

Идентификаторы

NCT: NCT07106996 · 82401924 · 8240062474

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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