NCT04120597

Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

Clinical and Basic Research on the Treatment of Zishen Qingre Lishi Huayu Method on Zin Deficiency and Dampness Type Polycystic Ovary Syndrome: a Multi-center, Double-blind, Randomized and Placebo-controlled Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Jiangxi University of Traditional Chinese Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Polycystic ovary syndrome is the most common endocrine and metabolic disorder in gynecology. Traditional Chinese medicine has a good clinical effect in the treatment of PCOS. We intend to conduct this trial in strict accordance with the requirements of evidence-based medicine, through a multi-center, randomized, controlled study, using a double-blind, randomized, placebo-controlled study design method to clarify that Zishen Qingre Lishi Huayu Recipe restores spontaneous ovulation in PCOS patients. The overall efficacy of improving the characteristics of Kaohsiung and glucose and lipid metabolism is optimal, and high-level evidence-based evidence is obtained to form a diagnosis and treatment plan for promotion.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Zishen Qingre Lishi Huayu Granules	The treatment group used Zishen Qingre Lishi Huayu Granules, including Zhimu（Anemarrhena asphodeloides Bge.）, Shengdi（Rehmannia glutinosa Libosch.）, Maidong（Ophio pogon japonicus (L.f) KerGawl.） , Bixie（Dioscorea septemloma Thunb.）, Huanglian（Coptis chinensis Franch.）, Zhuling（Polyporus umbellatus（Pers.）Fries）, Xuanshen（Scrophularia ningpoensis Hemsl.）, Zelan（Lycopus lucidus Turcz. Var. Hirtus Regel）, Danshen（Salvia miltiorrhiza Beg.）， Gancao（Glycyrrhiza uralensis Fisch.）. Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.
DRUG	Placebo	The treatment group used Caramel pigment、 Ku Ding Cha Extracts、Maltodextrin、Starch and 5% Zishen Qingre Lishi Huayu Granules . Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.

Timeline

• Start date: 2019-12-23
• Primary completion: 2021-08-20
• Completion: 2021-09-06
• First posted: 2019-10-09
• Last updated: 2023-07-18

Locations

1 site across 1 country: China