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| ID | Type | Description | Link |
|---|---|---|---|
| 8240062474 | Other Identifier | the National Natural Science Foundation of China |
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| Name | Class |
|---|---|
| Lishui Hospital of Traditional Chinese Medicine | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| red yeast rice，RYR | Drug | Participants will take 6 grams of red yeast rice daily for 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| inflammatory marker IL18 [pg/ml] | Baseline, the 3rd month and the 6th month after the intervention | |
| inflammatory marker IL1β [pg/ml] | Baseline, the 3rd month and the 6th month after the intervention | |
| testosterone (nmol/l) | Baseline, the 3rd month and the 6th month after the intervention | |
| Follicle - Stimulating Hormone (mIU/mL) | Baseline, the 3rd month and the 6th month after the intervention | |
| Luteinizing Hormone (mIU/mL) | Baseline, the 3rd month and the 6th month after the intervention | |
| Estradiol (pmol/l) | Baseline, the 3rd month and the 6th month after the intervention | |
| Progesterone (ng/mL) | Baseline, the 3rd month and the 6th month after the intervention | |
| Prolactin (ng/mL) | 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. | Baseline, the 3rd month and the 6th month after the intervention |
| ovarian volume(Length x Width x Thickness/2,ml) |
| Measure | Description | Time Frame |
|---|---|---|
| Body-mass-index (BMI) | BMI measured with the formula BMI=weight [kg]/height² [m] | Baseline, the 3rd month and the 6th month after the intervention |
| waist-to-hip ratio | Calculated with the formula: waist circumference/hip circumference |
| Measure | Description | Time Frame |
|---|---|---|
| The metagenomics of fecal samples | Total DNA of fecal samples is extracted by CTAB method. | before the intervention, at the 3rd month and the 6th month after the intervention |
| Non-targeted metabolomic analysis of fecal and serum samples |
Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lishui Hospital of Traditional Chinese Medicine | Recruiting | Lishui | Zhejiang | 323000 | China |
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The size of each ovary in each participant will be determined by ultrasonography. |
| Baseline, the 3rd month and the 6th month after the intervention |
| Follicle diameter(mm) | The diameter of the follicles will be determined by ultrasonography. | Baseline, the 3rd month and the 6th month after the intervention |
| Hydroxyindole concentration | Baseline, the 3rd month and the 6th month after the intervention |
| Baseline, the 3rd month and the 6th month after the intervention |
Fecal and serum samples were subjected to untargeted metabolomic detection using LC-MS/MS with an Agilent UHPLC system coupled to an Agilent 6538 UHD and Accurate-Mass Q-TOF mass spectrometer. Metabolites in the samples were separated, identified, and their information was acquired. Univariate and multivariate analyses were performed on the metabolites to screen for significantly differential metabolites before and after treatment.
| before the intervention, at the 3rd month and the 6th month after the intervention |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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