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

Aijun Sun

Status and phase: Unknown; Phase 2

Conditions: PCOS

Treatments: Drug: Diane-35; Drug: Dingkundan & Diane-35; Drug: Dingkundan

Study type: Interventional

Funder types: Other

Identifiers

NCT03264638

PCOS201708

Details and patient eligibility

About

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.

Full 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.

Enrollment: 315 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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315 participants in 3 patient groups

Dingkundan

Experimental group

Description:

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

Treatment:

Drug: Dingkundan

Dingkundan & Diane-35

Experimental group

Description:

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

Treatment:

Drug: Dingkundan & Diane-35

Diane-35

Active Comparator group

Description:

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

Treatment:

Drug: Diane-35