Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Zishen Qingre Lishi Huayu Granules

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Hyperprolactinemia: In the past year, patients with normal levels can be included.
2. Menopausal FSH levels：FSH > 15 mIU/mL. In the past year, patients with normal levels can be included.
3. 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.
4. Patients with poorly controlled type 2 diabetes:HbA1c>7.0%, or patients receiving antidiabetic drugs.
5. Patients currently diagnosed with severe anemia (HGB <10 g/dL).
6. Patients with a history of alcohol abuse: Alcohol is defined as drinking 14 times a week or more or binge drinking.
7. Currently suspected Cushing's syndrome patients.
8. Patients suspected of having adrenal or ovarian tumors secreting androgen.
9. 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.
10. Patients currently diagnosed with metabolic syndrome
11. Take hormonal drugs, Chinese medicine prescriptions and proprietary Chinese medicines in the last 3 months.
12. There is a history of pregnancy in the last 6 weeks.
13. Abortion or production history in the last 6 weeks.
14. A history of breastfeeding in the last 6 months.
15. Patients with a history of deep vein thrombosis, pulmonary embolism or cerebrovascular disease.
16. Patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, and mental patients
17. Patients who are expected to discontinue treatment during the trial or who are unable to adhere to treatment for 3 months should be excluded.
18. Reluctant to sign the informed consent form for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	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.
Experimental: Therapy group	Drug: Zishen Qingre Lishi Huayu Granules; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ovulation rate	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).	The 3-month treatment

Collaborators and Investigators

• Sponsor: Jiangxi University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2019
• Primary Completion (Actual): August 20, 2021
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome
• Other Study ID Numbers: S2018ZPYFE0937

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No