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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Tang-Du Hospital | OTHER |
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This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in adults women. One third of participants will receive Dingkundan capsules, one third of participants will receive Diane-35 Pills, and the another third will receive Dingkundan capsules and Diane-35 in combination.
Dingkundan,Diane-35 each ameliorate PCOS, but they do so by different mechanisms. We generally treat PCOS patients without immediate fertility requirement by short-acting contraceptives,Diane-35 is one of the most commonly used drugs.
Dingkundan consists of multiple chinese herbs including ginseng,Panax notoginseng,deer antlers,Carthamus tinctorius L.,Radix Paeoniae Alba,prepared Radix Rehmanniae,Angelica etc., which gains widespread application in the treatment of gynecological diseases. Based on the characteristics above, we try to explore its clinical application value in PCOS and its biological mechanisms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dingkundan | Experimental | Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles |
|
| Dingkundan & Diane-35 | Experimental | Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles |
|
| Diane-35 | Active Comparator | Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dingkundan | Drug | Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles |
| Measure | Description | Time Frame |
|---|---|---|
| symptoms | PCOS symptoms | 5 minutes |
| sex hormone levels changes | sex hormone levels changes | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| lipid metabolism | blood lipid profile | 5 minutes |
| metabolites figure spectrum | metabolites figure spectrum to undermine the mechanism of Dingkundan and Diane-35 in the treatment of PCOS |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li, MD | Contact | 139-1198-8831 | +86 | lileigh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Aijun Sun, MD | Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | China/Beiing | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14688154 | Background | Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod. 2004 Jan;19(1):41-7. doi: 10.1093/humrep/deh098. | |
| 28732568 | Background | Amiri M, Ramezani Tehrani F, Nahidi F, Kabir A, Azizi F, Carmina E. Effects of oral contraceptives on metabolic profile in women with polycystic ovary syndrome: A meta-analysis comparing products containing cyproterone acetate with third generation progestins. Metabolism. 2017 Aug;73:22-35. doi: 10.1016/j.metabol.2017.05.001. Epub 2017 May 10. |
| Label | URL |
|---|---|
| Diane can be used to ameliorate acne in PCOS patients | View source |
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Network platform, and the website will be attached later.
Within 2 months after the trial complete
Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement
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| ID | Term |
|---|---|
| C032640 | Cyproterone acetate, ethinyl estradiol drug combination |
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One third of participanta will receive Dingkun Dan Pills, one third of participanta will receive Diane-35 Pills, and the another third will receive Dingkun Dan pills and Diane-35 in combination.
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| Dingkundan & Diane-35 | Drug | Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles |
|
|
| Diane-35 | Drug | Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles |
|
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| 5 minutes |
| Fasting insulin | Fasting insulin | 5 minutes |
| glycosylated hemoglobin | glycosylated hemoglobin | 5 minutes |
| fasting blood glucose | fasting blood glucose | 5 minutes |
| 34873082 | Derived | Ding X, Deng Y, Wang Y, Xue W, Zhu S, Ma X, Ma R, Sun A. Serum metabolomic profiling reveals potential biomarkers in assessing the management of women with polycystic ovary syndrome: a randomized controlled trial. Chin Med J (Engl). 2022 Jan 5;135(1):79-85. doi: 10.1097/CM9.0000000000001705. |
| 32915426 | Derived | Deng Y, Wang YF, Zhu SY, Ma X, Xue W, Ma RL, Sun AJ. Is There An Advantage of Using Dingkun Pill () alone or in Combination with Diane-35 for Management of Polycystic Ovary Syndrome? A Randomized Controlled Trial. Chin J Integr Med. 2020 Dec;26(12):883-889. doi: 10.1007/s11655-020-3097-4. Epub 2020 Sep 11. |
| 31236888 | Derived | Deng Y, Xue W, Wang YF, Liu XH, Zhu SY, Ma X, Zuo HL, Jiang JF, Zheng TP, Sun AJ. Insulin Resistance in Polycystic Ovary Syndrome Improved by Chinese Medicine Dingkun Pill (): A Randomized Controlled Clinical Trial. Chin J Integr Med. 2019 Apr;25(4):246-251. doi: 10.1007/s11655-018-2947-1. Epub 2019 Jun 25. |