Clinical trial NCT03264638: A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of PCOS
Official title: A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: PCOS
Keywords: PCOS
Dingkundan
Diane-35
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Tang-Du Hospital
First posted: 2017-08-29
Enrollment: 315
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subject is a female between the age of 18 and 40.
* Subject diagnosed as PCOS by the 2003 Rotterdam criteria.
* Subject provides written informed consent.

Exclusion Criteria:

* Subject has other endocrine diseases,such as adrenal hyperplasias or tumor, androgen-secreting tumours, Cushing's syndrome,thyroid diseases and hyperprolactinemia.
* 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.

Primary outcomes:
measure: symptoms
timeFrame: 5 minutes
measure: sex hormone levels changes
timeFrame: 5 minutes
Secondary outcomes:
measure: lipid metabolism
timeFrame: 5 minutes
measure: metabolites figure spectrum
timeFrame: 5 minutes
measure: Fasting insulin
timeFrame: 5 minutes
measure: glycosylated hemoglobin
timeFrame: 5 minutes
measure: fasting blood glucose
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: China/Beiing
Study officials:
affiliation: Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences
name: Aijun Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.