Perimenopausal SyndromePhase 4NCT07606755
Clinical Efficacy Study of Jinfeng Pill in the Treatment of Perimenopausal Syndrome
A Phase 4 study testing Jinfeng Pill in people with Perimenopausal Syndrome, run by Tongji Hospital at 3 sites in China.
Trial summary
Perimenopausal syndrome (PMS) is a common condition affecting women during the transition to menopause, often causing hot flashes, sweating, insomnia, anxiety, depression, fatigue, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Perimenopausal Syndrome
- What is being tested?
- Jinfeng Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 10 May 2026to 1 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 45-55 years;
- Menstrual disorders (prolonged menstrual cycle or hypomenorrhea) lasting for more than 3 months, or amenorrhea for 2-12 months;
- Presence of vasomotor symptoms (hot flashes, sweating), somatic symptoms (insomnia, fatigue, headache, paresthesia), psychological symptoms (anxiety, depression), or urogenital symptoms (dyspareunia, vaginal dryness, urinary tract infection);
- Serum follicle-stimulating hormone (FSH) > 10 IU/L, or decreased estradiol (E2) levels;
- No use of HRT or other medications for perimenopausal symptoms in the past 2 months;
- Intact uterus and bilateral adnexa, not surgically removed;
- Voluntary participation and signing of informed consent;
- Modified Kupperman Index (KI score) ≥ 6, indicating mild or above symptoms.
Who cannot join
- Does not meet the inclusion criteria listed above;
- Ovarian malignancy, ovarian or hysterectomy, premature ovarian failure, uterine fibroids ≥2 cm, severe breast hyperplasia;
- Acute gynecological infectious diseases or other acute infectious diseases;
- Severe liver or kidney dysfunction, or other serious systemic diseases;
- Use of hormonal drugs or traditional Chinese medicine for treatment in the past 2 months;
- Participation in other clinical trials;
- Patients who did not adhere to the treatment protocol or withdrew from the trial;
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Hubei Maternal and Child Health Hospital,Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Man Tian, +8615007163910, 396617040@qq.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Xiao Wu Dr, +8613237124563, wuxiao0609@163.com
- Recruiting
Wuhan Children's Hospital (Wuhan Maternal and Child Health Hospital),Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Lishan Zhou, +8618086029059, sophiachou0913@126.com
About this study
Perimenopausal syndrome (PMS) is a common condition affecting women during the transition to menopause, often causing hot flashes, sweating, insomnia, anxiety, depression, fatigue, and reduced quality of life. Current hormone replacement therapy can improve symptoms, but long-term use may increase the risk of breast cancer and cardiovascular complications. Therefore, safer and more effective alternative treatments are needed.
Jinfeng Pill is a traditional Chinese medicine patented drug that has been widely used in gynecological disorders. Previous studies suggest that it may help regulate hormone balance, improve ovarian function, and reduce inflammation. Recent research has also shown that intestinal bacteria ("gut microbiota") may influence estrogen metabolism through the "gut microbiota-estrogen axis," which could play an important role in perimenopausal symptoms.
Read more
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness and safety of Jinfeng Pill in women with perimenopausal syndrome. Eligible participants will be randomly assigned to receive either Jinfeng Pill or a placebo for 12 weeks. Researchers will assess changes in menopausal symptoms, mood, sleep, and quality of life using standardized questionnaires and laboratory tests.
In addition, the study will explore how Jinfeng Pill may regulate gut microbiota, β-glucuronidase (β-GUS) activity, short-chain fatty acids (SCFAs), inflammatory factors, and estrogen-related indicators. The findings may provide new evidence for the clinical use of traditional Chinese medicine in the treatment of perimenopausal syndrome and help clarify its underlying biological mechanisms.
- Conditions
- Perimenopausal Syndrome
- Being tested
- Jinfeng Pill, Placebo
- Keywords
- Perimenopausal Syndrome, Jinfeng Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jinfeng PillDrug
Jinfeng Pill
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Placebo Receives: Drug: Placebo |
| Jinfeng Pill group | Experimental | Jinfeng Pill Receives: Drug: Jinfeng Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Kupperman Index (KI)
The total score of KI is 63. It includes 13 items related to peri-menopausal syndrome, and the severity score of each item ranges from 0 to 3. There were different basic score in each item: hot flashes and sweating = 4; Paresthesia, sleep disorders, nervousness, sexual complaints, urinary tract infection = 2; the other items = 1. Item score = basic score × severity score. Classification standard of disease condition: mild: symptom score <13; moderate: symptom score 14-26; severe: symptom score >27 points.
Measured: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16
Secondary outcomes (11)
Hot flash scale (HFs)
The severity of hot flash was evaluated using visual analog scale (0-10).The higher the value, the more severe the symptoms.
Measured: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16
Menopause-specific quality of life scale (MENQOL)
MENQOL contains 27 questions related to vasomotor symptoms, psychological symptoms, physiological symptoms, and sexual life. A lower MENQOL score indicates PMPS has a less influence on life quality.
Measured: Week 0, Week 12, Week 16
Hamilton depressive scale (HAMD)
The items of HAMD are scored on a 5-level scale with 0-4 points, a few items is a 3-level scale with 0-2 points. A higher score indicates the more severe depression.
Measured: Week 0, Week 12, Week 16
Hamilton anxiety scale (HAMA)
HAMA contains 14 items related to a number of anxiety symptoms. Each of items is scored on a 5-level scale with 0-4 points. A higher score indicates the more severe anxiety.
Measured: Week 0, Week 12, Week 16
Vaginal Health Index (VHI)
The VHIS (Vaginal Health Index) comprises five assessment dimensions, each scored from 1 to 5 points, for a total of 25 points. A higher total score indicates better vaginal health, while a total score below 15 points suggests vaginal atrophy.
Measured: Week 0, Week 12
TCM Syndrome Score Scale
Symptom severity will be graded according to the Guiding Principles for Clinical Research of New Chinese Medicines for eight TCM-specific symptom domains (hot flushes and sweating, menstrual irregularity, irritability, dizziness and headache, lumbar and knee soreness, insomnia with vivid dreaming, hypochondriac pain with bitter taste, and vaginal dryness), each rated 0-3 (absent/mild/moderate/severe). The total score is 24 points, with higher scores indicating more severe symptoms.
Measured: Week 0, Week 12
Serum levels of sex hormones (E2, FSH, LH) and estrogen metabolites (2-OHE1,16α-OHE1)
Serum E2, FSH, and LH will be quantified by enzyme-linked immunosorbent assay (ELISA). Estrogen metabolites - 2-hydroxyestrone (2-OHE1) and 16α-hydroxyestrone (16α-OHE1) - will be determined by liquid chromatography-mass spectrometry (LC-MS).
Measured: Week 0, Week 12
Serum inflammatory factors (IL-6, TNF-α)
Serum concentrations of interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNF-α) will be measured by ELISA
Measured: Week 0, Week 12
Intestinal microbiota β-GUS enzyme activity
β-GUS activity will be determined spectrophotometrically via the enzymatic hydrolysis of p-nitrophenyl-β-D-glucuronide (pNPG) to p-nitrophenol (pNP), quantified by absorbance at 405 nm.
Measured: Week 0, Week 12
Short-Chain Fatty Acids (SCFAs)
Faecal concentrations of acetic acid, propionic acid, and butyric acid will be determined by gas chromatography.
Measured: Week 0, Week 12
Gut Microbiota Analysis
Faecal samples will be collected at baseline and week 12. Participants will provide ≥5 mg of stool into a sterile collection tube, which will be immediately snap-frozen in liquid nitrogen and stored at -80°C pending analysis. Bacterial genomic DNA will be extracted using the QIAamp Swab DNA Kit (QIAGEN). The V3-V4 hypervariable regions of the 16S rRNA gene will be amplified by PCR and sequenced on the Illumina NextSeq 2000 platform.
Measured: Week 0, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start10 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal SyndromeStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohu Xu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606755
- Sponsor's protocol ID
- TJ-IRB202512083
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protecting participant privacy and data security.To consider potential data needs, please contact authorized researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Study of Jinfeng Pill in the Treatment of Perimenopausal Syndrome
- ClinicalTrials.gov ID
- NCT07606755
- Acronym / sponsor ID
- TJ-IRB202512083
- Conditions
- Perimenopausal Syndrome
- Keywords
- Perimenopausal Syndrome, Jinfeng Pill
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 26 May 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.
Perimenopausal syndrome (PMS) is a common condition affecting women during the transition to menopause, often causing hot flashes, sweating, insomnia, anxiety, depression, fatigue, and reduced quality of life. Current hormone replacement therapy can improve symptoms, but long-term use may increase the risk of breast cancer and cardiovascular complications. Therefore, safer and more effective alternative treatments are needed.
Jinfeng Pill is a traditional Chinese medicine patented drug that has been widely used in gynecological disorders. Previous studies suggest that it may help regulate hormone balance, improve ovarian function, and reduce inflammation. Recent research has also shown that intestinal bacteria ("gut microbiota") may influence estrogen metabolism through the "gut microbiota-estrogen axis," which could play an important role in perimenopausal symptoms.
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness and safety of Jinfeng Pill in women with perimenopausal syndrome. Eligible participants will be randomly assigned to receive either Jinfeng Pill or a placebo for 12 weeks. Researchers will assess changes in menopausal symptoms, mood, sleep, and quality of life using standardized questionnaires and laboratory tests.
In addition, the study will explore how Jinfeng Pill may regulate gut microbiota, β-glucuronidase (β-GUS) activity, short-chain fatty acids (SCFAs), inflammatory factors, and estrogen-related indicators. The findings may provide new evidence for the clinical use of traditional Chinese medicine in the treatment of perimenopausal syndrome and help clarify its underlying biological mechanisms.
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 |
|---|---|---|
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo |
| Jinfeng Pill group | Experimental | Drug: Jinfeng PillJinfeng Pill |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female patients aged 45-55 years;
- Menstrual disorders (prolonged menstrual cycle or hypomenorrhea) lasting for more than 3 months, or amenorrhea for 2-12 months;
- Presence of vasomotor symptoms (hot flashes, sweating), somatic symptoms (insomnia, fatigue, headache, paresthesia), psychological symptoms (anxiety, depression), or urogenital symptoms (dyspareunia, vaginal dryness, urinary tract infection);
- Serum follicle-stimulating hormone (FSH) > 10 IU/L, or decreased estradiol (E2) levels;
- No use of HRT or other medications for perimenopausal symptoms in the past 2 months;
Key exclusion criteria (7 listed)
- Does not meet the inclusion criteria listed above;
- Ovarian malignancy, ovarian or hysterectomy, premature ovarian failure, uterine fibroids ≥2 cm, severe breast hyperplasia;
- Acute gynecological infectious diseases or other acute infectious diseases;
- Severe liver or kidney dysfunction, or other serious systemic diseases;
- Use of hormonal drugs or traditional Chinese medicine for treatment in the past 2 months;
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 |
|---|---|---|
| Jinfeng PillJinfeng Pill | Drug | Jinfeng Pill group |
| PlaceboPlacebo | Drug | Placebo group |
Primary outcome
The modified Kupperman Index (KI)
Time frame: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16
The total score of KI is 63. It includes 13 items related to peri-menopausal syndrome, and the severity score of each item ranges from 0 to 3. There were different basic score in each item: hot flashes and sweating = 4; Paresthesia, sleep disorders, nervousness, sexual complaints, urinary tract infection = 2; the other items = 1. Item score = basic score × severity score. Classification standard of disease condition: mild: symptom score <13; moderate: symptom score 14-26; severe: symptom score >27 points.
11 secondary outcomes
Hot flash scale (HFs)
Time frame: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16
Menopause-specific quality of life scale (MENQOL)
Time frame: Week 0, Week 12, Week 16
Hamilton depressive scale (HAMD)
Time frame: Week 0, Week 12, Week 16
Hamilton anxiety scale (HAMA)
Time frame: Week 0, Week 12, Week 16
Vaginal Health Index (VHI)
Time frame: Week 0, Week 12
TCM Syndrome Score Scale
Time frame: Week 0, Week 12
Serum levels of sex hormones (E2, FSH, LH) and estrogen metabolites (2-OHE1,16α-OHE1)
Time frame: Week 0, Week 12
Serum inflammatory factors (IL-6, TNF-α)
Time frame: Week 0, Week 12
Intestinal microbiota β-GUS enzyme activity
Time frame: Week 0, Week 12
Short-Chain Fatty Acids (SCFAs)
Time frame: Week 0, Week 12
Gut Microbiota Analysis
Time frame: Week 0, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. Protecting participant privacy and data security.To consider potential data needs, please contact authorized researchers.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Jinfeng Pill in people with Perimenopausal Syndrome, run by Tongji Hospital at 3 sites 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 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 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohu Xu (+8613006111902, hermanxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Kupperman Index (KI) (time frame: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16). 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 26 May 2026.