Status:
COMPLETED
Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome
Lead Sponsor:
Jiangxi University of Traditional Chinese Medicine
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2021
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04120597
Start Date
December 23 2019
End Date
September 6 2021
Last Update
July 18 2023
Active Locations (1)
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1
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China