Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

Jiangxi University of Traditional Chinese Medicine

Status and phase: Completed; Phase 2; Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Placebo; Drug: Zishen Qingre Lishi Huayu Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT04120597

S2018ZPYFE0937

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

Therapy group

Experimental group

Treatment:

Drug: Zishen Qingre Lishi Huayu Granules

Control group

Placebo Comparator group

Treatment:

Drug: Placebo