A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of PCOS
NCT ID: NCT03264638
Last Updated: 2018-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
315 participants
INTERVENTIONAL
2016-10-01
2018-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dingkundan
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
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
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
Dingkundan & Diane-35
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
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
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
Interventions
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Dingkundan
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject diagnosed as PCOS by the 2003 Rotterdam criteria.
* Subject provides written informed consent.
Exclusion Criteria
* Subject has received related medical or surgical treatment in the past 3 months.
* Subject suffered from substance abuse or dependence(such as alcohol or drugs);
* Subject is a heavy smoker(reaching or more than 20 cigarettes a day).
* Subject is pregnant or lactating or within 1 year after delivery.
* Subject has a severe systemic disease, such as cardiovascular system
* Subject has a history of malignancy or radiotherapy.
* Subject has an allergic history to the drugs used in the study.
* Subject has mental disorder incapable of elementary cooperations.
* Subject has participated in other clinical researches of medicine within 3 month prior to randomization.
18 Years
40 Years
FEMALE
Yes
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Tang-Du Hospital
OTHER
Aijun Sun
OTHER
Responsible Party
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Aijun Sun
Principal Investigator
Principal Investigators
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Aijun Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences
Locations
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Lei Li
Beijing, China/Beiing, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Related Links
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Diane can be used to ameliorate acne in PCOS patients
Other Identifiers
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PCOS201708
Identifier Type: -
Identifier Source: org_study_id
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