Polycystic Ovary SyndromePhase 1/2NCT05976295
Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
A Phase 1/2 study testing Jianpi Qushi Huatan Decoction in people with Polycystic Ovary Syndrome, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
Trial 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 the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Jianpi Qushi Huatan Decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2023to 1 Dec 2025
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The diagnosis of PCOS is based on the Rotterdam criteria.
- Meet the syndrome differentiation standard of spleen deficiency and phlegm-dampness in TCM theory.
- women aged 18-40 years without fertility requirements.
- A willingness to undergo this treatment plan.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi
Liang Ruining, 0086-0791-88385243, jack169@sina.com
About this study
Official title: Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Trial
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 the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. Therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of Chinese herbal medicine (Jianpi Qushi Huatan Decoction) in women with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Jianpi Qushi Huatan Decoction, 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.
Jianpi Qushi Huatan DecoctionDrug
The treatment group will receive the Jianpi Qushi Huatan Decoction (consisting of Radix astragali, Atractylodes Lancea, Dioscorea oppositifolia, Cyperus rotundus, Lindera aggregata, Aconitum gymnandrum and Ligusticum wallichii, among others). Subjects will take the medication from the first day of inclusion, dissolving and consuming one packet twice a day (morning and evening) for a total of three months.
PlaceboDrug
The control group will receive a placebo treatment.
| Study group | Role | What they receive |
|---|---|---|
| Therapy group | Experimental | Not described Receives: Drug: Jianpi Qushi Huatan Decoction |
| 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 in each group during the study period.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start31 Aug 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
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
- 68 participants (estimated)
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
- NCT05976295
- Sponsor's protocol ID
- 20223BBG71012-2
- Status last verified
- Sep 2023
- First submitted
- 27 Jul 2023
- Last updated
- 8 Sep 2023
- 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05976295
- Acronym / sponsor ID
- 20223BBG71012-2
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Aug 2023 (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 (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 the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. Therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of Chinese herbal medicine (Jianpi Qushi Huatan Decoction) in women with PCOS.
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: Jianpi Qushi Huatan Decoction |
| Control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The diagnosis of PCOS is based on the Rotterdam criteria.
- Meet the syndrome differentiation standard of spleen deficiency and phlegm-dampness in TCM theory.
- women aged 18-40 years without fertility requirements.
- A willingness to undergo this treatment plan.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Jianpi Qushi Huatan DecoctionThe treatment group will receive the Jianpi Qushi Huatan Decoction (consisting of Radix astragali, Atractylodes Lancea, Dioscorea oppositifolia, Cyperus rotundus, Lindera aggregata, Aconitum gymnandrum and Ligusticum wallichii, among others). Subjects will take the medication from the first day of inclusion, dissolving and consuming one packet twice a day (morning and evening) for a total of three months. | Drug | Therapy group |
| PlaceboThe control group will receive a placebo treatment. | Drug | Control group |
Primary outcome
Ovulation rate
Time frame: 3 months
Ovulation rate in each group during the study period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
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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.
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 Jianpi Qushi Huatan Decoction 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liang Ruining (0086-0791-88385243, jack169@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation rate (time frame: 3 months). 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 8 Sep 2023.