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

February 2, 2018 updated by: Aijun Sun

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

315

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • China/Beiing
      • Beijing, China/Beiing, China, 100000
        • Recruiting
        • Lei Li
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • B

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lipid metabolism
Time Frame: 5 minutes
blood lipid profile
5 minutes
metabolites figure spectrum
Time Frame: 5 minutes
metabolites figure spectrum to undermine the mechanism of Dingkundan and Diane-35 in the treatment of PCOS
5 minutes
Fasting insulin
Time Frame: 5 minutes
Fasting insulin
5 minutes
glycosylated hemoglobin
Time Frame: 5 minutes
glycosylated hemoglobin
5 minutes
fasting blood glucose
Time Frame: 5 minutes
fasting blood glucose
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aijun Sun

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Tang-Du Hospital

Investigators

  • Principal Investigator: Aijun Sun, MD, Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Anticipated)

August 31, 2018

Study Completion (Anticipated)

August 31, 2018

Study Registration Dates

First Submitted

August 13, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCOS201708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Network platform, and the website will be attached later.

IPD Sharing Time Frame

Within 2 months after the trial complete

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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