Polycystic Ovary SyndromePhase 1/2NCT04120597
Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome
A Phase 1/2 study testing Zishen Qingre Lishi Huayu Granules in people with Polycystic Ovary Syndrome, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
Trial 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 trial in strict accordance with the requirements of evidence-based medicine, through a multi-center, randomized… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Zishen Qingre Lishi Huayu Granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2019to 6 Sep 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed as PCOS patients, the diagnostic criteria are 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi
About this study
Official title: Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome With Zishen Qingre Lishi Huayu Method: a Multi-center, Double-blind, Randomized and Placebo-controlled Study
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Zishen Qingre Lishi Huayu Granules, Placebo
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zishen Qingre Lishi Huayu GranulesDrug
The treatment group used Zishen Qingre Lishi Huayu Granules, including Zhimu（Anemarrhena asphodeloides Bge., Shengdi（Rehmannia glutinosa Libosch.), Qumai (Dianthus superbus L.), Shihu (Dendrobium nobile Lindl.), Taoren (Prunus persica (L.) Batsch), Gualouren (Trichosanthes kirilowii Maxim.), Huanglian (Coptis chinensis Franch.), Huangbai (Phellodendron amurense Rupr.), Guizhi (Cinnamomum cassia Presl.), Cheqiancao (Plantago asiatica L.), Gancao（Glycyrrhiza uralensis Fisch.）. Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapy group | Experimental | Not described Receives: Drug: Zishen Qingre Lishi Huayu Granules |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The 3-month treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start23 Dec 2019
- Primary completion20 Aug 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruining Liang, Jiangxi University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120597
- Sponsor's protocol ID
- S2018ZPYFE0937
- Status last verified
- Jul 2023
- First submitted
- 29 Sep 2019
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome With Zishen Qingre Lishi Huayu Method: a Multi-center, Double-blind, Randomized and Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04120597
- Acronym / sponsor ID
- S2018ZPYFE0937
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy group | Experimental | Drug: Zishen Qingre Lishi Huayu Granules |
| Control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed as PCOS patients, the diagnostic criteria are 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zishen Qingre Lishi Huayu GranulesThe treatment group used Zishen Qingre Lishi Huayu Granules, including Zhimu（Anemarrhena asphodeloides Bge., Shengdi（Rehmannia glutinosa Libosch.), Qumai (Dianthus superbus L.), Shihu (Dendrobium nobile Lindl.), Taoren (Prunus persica (L.) Batsch), Gualouren (Trichosanthes kirilowii Maxim.), Huanglian (Coptis chinensis Franch.), Huangbai (Phellodendron amurense Rupr.), Guizhi (Cinnamomum cassia Presl.), Cheqiancao (Plantago asiatica L.), Gancao（Glycyrrhiza uralensis Fisch.）. Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months. | Drug | Therapy group |
| PlaceboThe 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. | Drug | Control group |
Primary outcome
Ovulation rate
Time frame: The 3-month treatment
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zishen Qingre Lishi Huayu Granules in people with Polycystic Ovary Syndrome, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation rate (time frame: The 3-month treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.