Status:
UNKNOWN
Efficacy of Bushen Huatan Decoction in 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 (PCOS) is a common reproductive disease associated with endocrine and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial for PCOS, but th...
Eligibility Criteria
Inclusion
- The diagnosis of PCOS is based on the Rotterdam criteria.
- Meet the syndrome differentiation standard of kidney-yang deficiency with phlegm-dampness and blood stasis in TCM theory.
- women aged 18-40 years without fertility requirements.
- A willingness to undergo this treatment plan.
Exclusion
- Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart).
- Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L.
- Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/mL or more than 5.5 mIU/mL.
- Suspected Cushing's syndrome.
- Adrenal or ovarian tumors secreting androgen.
- Poorly controlled type II diabetes.
- Pregnancy or lactation.
- Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmHg or a diastolic blood pressure more than 100 mmHg).
- Those who had taken hormones or other drugs during the previous 3 months.
- Acute heart, liver, kidney or blood diseases.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05976308
Start Date
September 1 2023
End Date
December 1 2025
Last Update
September 8 2023
Active Locations (1)
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1
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China