Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed as PCOS patients, the diagnostic criteria are the Rotterdam criteria. All subjects must have: no ovulation, combined with polycystic ovarian or / and hyperandrogenism.
Age: 20 to 40 years old, no maternity requirements.
Willing to be treated according to the treatment plan specified in this study.

Exclusion criteria

Hyperprolactinemia: In the past year, patients with normal levels can be included.
Menopausal FSH levels：FSH > 15 mIU/mL. In the past year, patients with normal levels can be included.
Patients with thyroid disease: TSH < 0.2 mIU/mL or >5.5 mIU/mL. In the past year, patients with normal levels can be included.
Patients with poorly controlled type 2 diabetes:HbA1c>7.0%, or patients receiving antidiabetic drugs.
Patients currently diagnosed with severe anemia (HGB <10 g/dL).
Patients with a history of alcohol abuse: Alcohol is defined as drinking 14 times a week or more or binge drinking.
Currently suspected Cushing's syndrome patients.
Patients suspected of having adrenal or ovarian tumors secreting androgen.
In patients with hypertension who are currently untreated or have poor blood pressure control, the interval between two blood pressure measurements is ≥ 60 min, systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg.
Patients currently diagnosed with metabolic syndrome
Take hormonal drugs, Chinese medicine prescriptions and proprietary Chinese medicines in the last 3 months.
There is a history of pregnancy in the last 6 weeks.
Abortion or production history in the last 6 weeks.
A history of breastfeeding in the last 6 months.
Patients with a history of deep vein thrombosis, pulmonary embolism or cerebrovascular disease.
Patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, and mental patients
Patients who are expected to discontinue treatment during the trial or who are unable to adhere to treatment for 3 months should be excluded.
Reluctant to sign the informed consent form for this study.

Treatment and study plan

Zishen Qingre Lishi Huayu Granules

Drug

The treatment group used Zishen Qingre Lishi Huayu Granules, including Zhimu（Anemarrhena asphodeloides Bge., Shengdi（Rehmannia glutinosa Libosch.), Qumai (Dianthus superbus L.), Shihu (Dendrobium nobile Lindl.), Taoren (Prunus persica (L.) Batsch), Gualouren (Trichosanthes kirilowii Maxim.), Huanglian (Coptis chinensis Franch.), Huangbai (Phellodendron amurense Rupr.), Guizhi (Cinnamomum cassia Presl.), Cheqiancao (Plantago asiatica L.), Gancao（Glycyrrhiza uralensis Fisch.）. Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.

Placebo

Drug

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.

Primary outcomes

Ovulation rate

Time frame: The 3-month treatment

Ovulation rate of each group during the study period Ovulation rate per group = actual total ovulation frequency / total number of cycles (total number of cycles = number of samples).

Sponsors and collaborators

Lead sponsor

Jiangxi University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Oct 9, 2019
Registry last updated: May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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