Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

Phase 1

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Placebo; Drug: Zishen Qingre Lishi Huayu Granules

• Registration Number: NCT04120597
• Lead Sponsor: Jiangxi University of Traditional Chinese Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2019-12-23
• Primary Completion: 2021-08-20
• Study Completion: 2021-09-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

1. Diagnosed as PCOS patients, the diagnostic criteria is: modify 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	-
Therapy group	Zishen Qingre Lishi Huayu Granules	-

Primary Outcome Measures

Name	Time	Method
Ovulation rate	The 3rd month	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).

Trial Locations

Locations (1)

The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine; 🇨🇳 Nanchang, Jiangxi, China