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Ancient herbal recipe put to the test for PCOS

NCT ID NCT04120597

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

126 people

The number who actually took part.

Started

Dec 2019

Finished

Sep 2021

Lead sponsor

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

20 to 40 years

Sex

Female participants only

Healthy volunteers

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

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

  • The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

    Nanchang, Jiangxi, China

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