Ancient herbal recipe put to the test for PCOS
NCT ID NCT04120597
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a traditional Chinese herbal mixture (Zishen Qingre Lishi Huayu) can help women with polycystic ovary syndrome (PCOS) ovulate more regularly. The trial involved 126 women aged 20 to 40 and used a double-blind, placebo-controlled design to measure ovulation rates and metabolic improvements. The goal was to gather strong evidence for a treatment that may help manage PCOS symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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126 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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Sep 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosed as PCOS patients, the diagnostic criteria are 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China
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Other studies related to the condition(s) this trial covers.
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