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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03264638
Recruitment Status : Unknown
Verified February 2018 by Aijun Sun, Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : August 29, 2017
Last Update Posted : February 5, 2018
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Tang-Du Hospital
Information provided by (Responsible Party):
Aijun Sun, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
PCOS Drug: Dingkundan Drug: Dingkundan & Diane-35 Drug: Diane-35 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of Polycystic Ovary Syndrome
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: 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
Other Name: A

Experimental: 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
Drug: 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
Other Name: A&B

Active Comparator: 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
Drug: 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 Name: B




Primary Outcome Measures :
  1. symptoms [ Time Frame: 5 minutes ]
    PCOS symptoms

  2. sex hormone levels changes [ Time Frame: 5 minutes ]
    sex hormone levels changes


Secondary Outcome Measures :
  1. lipid metabolism [ Time Frame: 5 minutes ]
    blood lipid profile

  2. metabolites figure spectrum [ Time Frame: 5 minutes ]
    metabolites figure spectrum to undermine the mechanism of Dingkundan and Diane-35 in the treatment of PCOS

  3. Fasting insulin [ Time Frame: 5 minutes ]
    Fasting insulin

  4. glycosylated hemoglobin [ Time Frame: 5 minutes ]
    glycosylated hemoglobin

  5. fasting blood glucose [ Time Frame: 5 minutes ]
    fasting blood glucose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264638


Contacts
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Contact: Lei Li, MD 139-1198-8831 ext +86 lileigh@163.com

Locations
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China, China/Beiing
Lei Li Recruiting
Beijing, China/Beiing, China, 100000
Contact: Lei L Li, MD    13911988831 ext +86    lileigh@163.com   
Sponsors and Collaborators
Aijun Sun
First Affiliated Hospital, Sun Yat-Sen University
Tang-Du Hospital
Investigators
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Principal Investigator: Aijun Sun, MD Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aijun Sun, Principal Investigator, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03264638    
Other Study ID Numbers: PCOS201708
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Network platform, and the website will be attached later.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Within 2 months after the trial complete
Access Criteria: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aijun Sun, Peking Union Medical College Hospital:
PCOS
Dingkundan
Diane-35
Additional relevant MeSH terms:
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Cyproterone Acetate
Cyproterone
Cyproterone acetate, ethinyl estradiol drug combination
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents