Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Zishen Qingre Lishi Huayu Granules
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy group<br> | Drug: Zishen Qingre Lishi Huayu Granules<br>* 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.<br>|
| Placebo Comparator: Control group<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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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 3rd month |