A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of PCOS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of Polycystic Ovary Syndrome

Conditions
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PCOS

Intervention / Treatment
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* Drug: Dingkundan
* Drug: Dingkundan & Diane-35
* Drug: Diane-35


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dingkundan<br>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 | Drug: Dingkundan<br>* 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<br>* Other names: A;|
| Experimental: Dingkundan & Diane-35<br>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 | Drug: Dingkundan & Diane-35<br>* 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<br>* Other names: A&B;|
| Active Comparator: Diane-35<br>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 | Drug: Diane-35<br>* 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<br>* Other names: B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms | PCOS symptoms | 5 minutes | 
| sex hormone levels changes | sex hormone levels changes | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | 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 | 5 minutes | 
| Fasting insulin | Fasting insulin | 5 minutes | 
| glycosylated hemoglobin | glycosylated hemoglobin | 5 minutes | 
| fasting blood glucose | fasting blood glucose | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, Dingkundan, Diane-35