Perimenopausal SymptomPhase 4NCT07912008
Clinical Study on the Efficacy and Safety of Heyan® Kuntai Capsules in Alleviating Perimenopausal Symptoms Induced by GnRH-a
A Phase 4 study testing Kuntai Capsule in people with Perimenopausal Symptom, run by Xintian Pharmaceutical at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Kuntai capsule works to treat perimenopausal symptoms caused by GnRH-a in adults. It will also learn about the safety of Kuntai capsule. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Perimenopausal Symptom
- What is being tested?
- Kuntai Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2024to 11 Feb 2026
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 45 years old who have not reached menopause;
- Patients diagnosed with endometriosis, uterine fibroids, uterine adenomyosis or any of these diseases after surgery, and who are scheduled to receive ≥ 3 courses of *GnRH-a treatment.
- Voluntary participants who agree to receive the treatment and sign the informed consent form.
Who cannot join
- For non-surgical patients, AMH should be less than 0.5 ng/mL within 3 months before enrollment, and for surgical patients, it should be less than 0.5 ng/mL after surgery.
- BMI should be ≥ 30 kg/m².
- Suspected or confirmed cases of gynecological malignancies such as breast cancer, ovarian cancer, endometrial cancer, etc.
- Within the past 2 months, have received treatment with drugs such as progestins, combined oral contraceptives (COC), GnRH-a and its analogues, danazol, etc., or have placed an intrauterine device (IUD) such as Mirena.
- Within the past 2 weeks, have taken herbal or traditional Chinese medicine that affects the efficacy of this study, such as Lifemin, Dingkundan, Zixin Yutai Pill, etc.
- Have severe diseases of the cardiovascular, nervous, liver, kidney, hematopoietic system or other systems, as well as mental disorders or intellectual disabilities.
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- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) should be more than 1.5 times the upper limit of the normal reference range, or serum creatinine (Scr) should be more than the upper limit of the normal reference range.
- Are currently participating in or have participated in other clinical trials within the past 3 months before screening.
- Are allergic or intolerant to the drugs or known drugs in the study formula.
- Have a habit of smoking more than 10 cigarettes per day within the past 3 months before screening.
- Patients with deficient yang constitution, such as those with thin stools or nocturnal diarrhea.
- History of drug abuse, drug addiction or alcoholism.
- Other patients deemed unsuitable to participate in this study by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 61554
About this study
Official title: Clinical Study on the Efficacy and Safety of Heyan® Kuntai Capsules in Relieving Perimenopausal Symptoms Induced by GnRH-a-A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
The goal of this clinical trial is to learn if Kuntai capsule works to treat perimenopausal symptoms caused by GnRH-a in adults. It will also learn about the safety of Kuntai capsule.
- Conditions
- Perimenopausal Symptom
- Being tested
- Kuntai Capsule, Placebo
- Keywords
- Perimenopausal, GnRH-a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kuntai CapsuleDrug
The ingredients include rehmannia glutinosa, coptis chinensis, white peony root, scutellaria baicalensis, donkey-hide gelatin, and poria cocos.
PlaceboDrug
The shape, color, smell and taste are all similar to Kuntai Capsules.
| Study group | Role | What they receive |
|---|---|---|
| Kuntai capsule | Experimental | Not described Receives: Drug: Kuntai Capsule |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Kupperman Index
Measured: at 4,8,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start26 Sep 2024
- Primary completion11 Feb 2026
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal SymptomStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xintian Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912008
- Sponsor's protocol ID
- KT-24-B-001-YJ-003
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Heyan® Kuntai Capsules in Relieving Perimenopausal Symptoms Induced by GnRH-a-A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07912008
- Acronym / sponsor ID
- KT-24-B-001-YJ-003
- Conditions
- Perimenopausal Symptom
- Keywords
- Perimenopausal, GnRH-a
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Xintian PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 3 Nov 2026 (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.
The goal of this clinical trial is to learn if Kuntai capsule works to treat perimenopausal symptoms caused by GnRH-a in adults. It will also learn about the safety of Kuntai capsule.
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 |
|---|---|---|
| Kuntai capsule | Experimental | Drug: Kuntai Capsule |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18 to 45 years old who have not reached menopause;
- Patients diagnosed with endometriosis, uterine fibroids, uterine adenomyosis or any of these diseases after surgery, and who are scheduled to receive ≥ 3 courses of *GnRH-a treatment.
- Voluntary participants who agree to receive the treatment and sign the informed consent form.
Key exclusion criteria (13 listed)
- For non-surgical patients, AMH should be less than 0.5 ng/mL within 3 months before enrollment, and for surgical patients, it should be less than 0.5 ng/mL after surgery.
- BMI should be ≥ 30 kg/m².
- Suspected or confirmed cases of gynecological malignancies such as breast cancer, ovarian cancer, endometrial cancer, etc.
- Within the past 2 months, have received treatment with drugs such as progestins, combined oral contraceptives (COC), GnRH-a and its analogues, danazol, etc., or have placed an intrauterine device (IUD) such as Mirena.
- Within the past 2 weeks, have taken herbal or traditional Chinese medicine that affects the efficacy of this study, such as Lifemin, Dingkundan, Zixin Yutai Pill, etc.
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 |
|---|---|---|
| Kuntai CapsuleThe ingredients include rehmannia glutinosa, coptis chinensis, white peony root, scutellaria baicalensis, donkey-hide gelatin, and poria cocos. | Drug | Kuntai capsule |
| PlaceboThe shape, color, smell and taste are all similar to Kuntai Capsules. | Drug | placebo |
Primary outcome
modified Kupperman Index
Time frame: at 4,8,12 weeks
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 3 Nov 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 4 study testing Kuntai Capsule in people with Perimenopausal Symptom, run by Xintian Pharmaceutical 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 13 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 3 Nov 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
modified Kupperman Index (time frame: at 4,8,12 weeks). 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 3 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.