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

PCOS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264638
• Other study ID #: PCOS201708
• Status: Recruiting
• Phase: Phase 2
• First received: August 13, 2017
• Last updated: February 2, 2018
• Start date: October 1, 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2018
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, MD
• Phone: 139-1198-8831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• PCOS

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
China	Lei Li	Beijing	China/Beiing

Sponsors (3)

Lead Sponsor	Collaborator
Aijun Sun	First Affiliated Hospital, Sun Yat-Sen University, Tang-Du Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms	PCOS symptoms	5 minutes
Primary	sex hormone levels changes	sex hormone levels changes	5 minutes
Secondary	lipid metabolism	blood lipid profile	5 minutes
Secondary	metabolites figure spectrum	metabolites figure spectrum to undermine the mechanism of Dingkundan and Diane-35 in the treatment of PCOS	5 minutes
Secondary	Fasting insulin	Fasting insulin	5 minutes
Secondary	glycosylated hemoglobin	glycosylated hemoglobin	5 minutes
Secondary	fasting blood glucose	fasting blood glucose	5 minutes

External Links

•   Diane can be used to ameliorate acne in PCOS patients
•   treatment of polycystic ovary syndrome