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

Sponsor

Aijun Sun (Other)

Overall Status

Unknown status

CT.gov ID

NCT03264638

Collaborator

First Affiliated Hospital, Sun Yat-Sen University (Other), Tang-Du Hospital (Other)

315

Enrollment

Location

Arms

Anticipated Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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.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 :

Oct 1, 2016

Anticipated Primary Completion Date :

Aug 31, 2018

Anticipated Study Completion Date :

Aug 31, 2018

Arms and Interventions

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

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:

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

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:

Outcome Measures

Primary Outcome Measures

symptoms [5 minutes]
PCOS symptoms
sex hormone levels changes [5 minutes]
sex hormone levels changes

Secondary Outcome Measures

lipid metabolism [5 minutes]
blood lipid profile
metabolites figure spectrum [5 minutes]
metabolites figure spectrum to undermine the mechanism of Dingkundan and Diane-35 in the treatment of PCOS
Fasting insulin [5 minutes]
Fasting insulin
glycosylated hemoglobin [5 minutes]
glycosylated hemoglobin
fasting blood glucose [5 minutes]
fasting blood glucose

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lei Li	Beijing	China/Beiing	China	100000

Sponsors and Collaborators

Aijun Sun
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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Aijun Sun, Principal Investigator, Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT03264638

Other Study ID Numbers:

PCOS201708

First Posted:

Aug 29, 2017

Last Update Posted:

Feb 5, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aijun Sun, Principal Investigator, Peking Union Medical College Hospital

PCOS

Dingkundan

Diane-35

Additional relevant MeSH terms:

Cyproterone Acetate

Cyproterone

Cyproterone acetate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Feb 5, 2018