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Polycystic ovary syndrome is the most common endocrine and metabolic disorder in gynecology. Traditional Chinese medicine has a good clinical effect in the treatment of PCOS. We intend to conduct this trial in strict accordance with the requirements of evidence-based medicine, through a multi-center, randomized, controlled study, using a double-blind, randomized, placebo-controlled study design method to clarify that Zishen Qingre Lishi Huayu Recipe restores spontaneous ovulation in PCOS patients. The overall efficacy of improving the characteristics of Kaohsiung and glucose and lipid metabolism is optimal, and high-level evidence-based evidence is obtained to form a diagnosis and treatment plan for promotion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy group | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zishen Qingre Lishi Huayu Granules | Drug | The treatment group used Zishen Qingre Lishi Huayu Granules, including Zhimu(Anemarrhena asphodeloides Bge., Shengdi(Rehmannia glutinosa Libosch.), Qumai (Dianthus superbus L.), Shihu (Dendrobium nobile Lindl.), Taoren (Prunus persica (L.) Batsch), Gualouren (Trichosanthes kirilowii Maxim.), Huanglian (Coptis chinensis Franch.), Huangbai (Phellodendron amurense Rupr.), Guizhi (Cinnamomum cassia Presl.), Cheqiancao (Plantago asiatica L.), Gancao(Glycyrrhiza uralensis Fisch.). Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Ovulation rate | Ovulation rate of each group during the study period Ovulation rate per group = actual total ovulation frequency / total number of cycles (total number of cycles = number of samples). | The 3-month treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine | Nanchang | Jiangxi | 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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|
| Placebo | Drug | The treatment group used Caramel pigment、 Ku Ding Cha Extracts、Maltodextrin、Starch and 5% Zishen Qingre Lishi Huayu Granules . Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months. |
|
| 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 |