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Tanshinone was originally isolated from dried roots of Salvia miltiorrhiza bunge. In Chinese medicine, this herb has been widely prescribed for several pathologies, including diabetes, acne, cardiovascular disease.It has been demonstrated that the therapeutic benefit of cryptotanshinone on prenatally androgenized rats may be mediated by its dual regulation of key molecules during both insulin signaling and androgen synthesis.The purpose of this study is to determine whether tanshinone may prove effective in eradicating Polycystic Ovary Syndrome (PCOS) symptomatology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tanshinone | Active Comparator | tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. |
|
| tanshinone placebo | Placebo Comparator | placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tanshinone | Drug | tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| basal testosterone | The primary outcome measure is a decrease in basal testosterone. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian androgen biosynthesis | Human chorionic gonadotropin (HCG) induced response of androgens including 17-hydroxyprogesterone (17-OHP), androstenedione (A2), testosterone (T) | 3 months |
| Whole body insulin action |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoke Wu, MD.PhD. | Contact | 13796025599 | xiaokewu2002@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoke Wu, docotor | The First Affliated Hospital,Heilongjiang University of Chinese Medicine . | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heilongjiang University of Chinese Medicine | Recruiting | Harbin | Heilongjiang | 150040 | 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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| ID | Term |
|---|---|
| C021751 | tanshinone |
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| tanshinone placebo | Drug | placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks. |
|
Insulin resistance by the glucose disposal rate (GDR) with hyperinsulinemic euglycemic clamp test
| 3 months |
| Oral glucose tolerance test (OGTT) | All the participants will undergo an overnight fast. After ingestion of a 75-g glucose load, blood samples will be obtained at 0, 30, 60, 90, and 120min for glucose and insulin level determination. | 3 months |
| Reproductive hormones | estradiol (E2), 17-α-hydroxyprogesterone (17-OHP), follicle stimulation hormone (FSH), leutinizing hormone (LH), sex hormone binding globulin and dehydroepiandrosterone sulphate. | 3 months |
| Fasting gluco-lipid metabolic profiles | 3 months |
| quality of life | the quality of life will be assessed by the Polycystic Ovary Syndrome Questionnaire (PCOS-QOL)and the Chinese Quality of Life (ChQOL). | 3 months |
| Weight, waist/hip circumference, blood pressure, F-G score and acne before and after treatment | 3 months |
| Adverse events | 3 months |
| Huaian Maternal and Child Health Hospital | Recruiting | Huaian | Jiangsu | 223001 | China |
|
| Lianyungang Maternal and Child Health Hospital | Active, not recruiting | Lianyungang | Jiangsu | 222000 | China |
| JiangXi University of Traditional Chinese Medicine | Completed | Nanchang | Jiangxi | 330000 | China |
| 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 |