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The goal of this clinical trial is to compare the clinical effect of Jinfeng Pill and Diane-35 in patients with PCOS. The main questions it aims to answer are: a. Comparison of the efficacy of the drugs separately and in combination. To explore the possible mechanism of Jinfeng pills. Participants will be treated for three months with monthly follow-up. Blood and stool samples should be collected.
In this study, the clinical efficacy of Jinfeng pill in the treatment of PCOS was evaluated, and the clinical systems biology research system was introduced to discuss the clinical mechanism of Jinfeng pill in the treatment of PCOS from the perspectives of metabolomics and intestinal flora, etc., and an integrated biomarker index system was established to evaluate the efficacy of Jinfeng pill in the treatment of PCOS. To clarify the action mechanism and pharmacodynamic material basis of Jinfeng pills in treating PCOS. According to the previous study, a total of 105 participants were included. They were required to complete three months of treatment and monthly follow-up visits. The main therapeutic index was improved level of sex hormone. Secondary efficacy indexes included symptom scale score and TCM scale score. It has also been explored to incorporate changes such as metabolomic molecules and gut microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jinfeng Pill Group | Experimental |
| |
| Jinfeng pill+Diane-35 Group | Experimental |
| |
| Jinfeng Pill(placebo)+Diane-35 Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jinfeng Pill | Drug | Jinfeng pills were compared with Diane-35 group and Jinfeng pills combined with Diane-35 group were compared with Diane-35 alone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sex hormone | FSH、 LH、 E2、 T、 PRL、 DS、 AMH | twice (before and after 3-month treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual status | patients were asked to record the day they menstruating, menstruation duration and the flow level (light/ medium/ heavy) and concomitant symptom | everyday during 3-month treatment |
| acne score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 1000730 | China |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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applying Global Acne Grading System(GAGS), scored by gynecologist
| twice (before and after 3-month treatment) |
| hirsutism score | applying Ferriman-Gallwey scoring system, scored by gynecologist | twice (before and after 3-month treatment) |
| Traditional Chinese Medicine Symptom Score | patient self-assessment scale, in Chinese | every month during 3-month treatment |
| 36-Item Short Form Survey | SF-36 is a self-reported survey that assesses physical and mental health outcomes. | every month during 3-month treatment |
| 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 |