Clinical Efficacy Study of Jinfeng Pill in the Treatment of Perimenopausal Syndrome

May 18, 2026 updated by: Xiaohu Xu, Tongji Hospital

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Hubei Maternal and Child Health Hospital,Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Wuhan Children's Hospital (Wuhan Maternal and Child Health Hospital),Tongji Medical College of Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female patients aged 45-55 years;
  2. Menstrual disorders (prolonged menstrual cycle or hypomenorrhea) lasting for more than 3 months, or amenorrhea for 2-12 months;
  3. 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);
  4. Serum follicle-stimulating hormone (FSH) > 10 IU/L, or decreased estradiol (E2) levels;
  5. No use of HRT or other medications for perimenopausal symptoms in the past 2 months;
  6. Intact uterus and bilateral adnexa, not surgically removed;
  7. Voluntary participation and signing of informed consent;
  8. Modified Kupperman Index (KI score) ≥ 6, indicating mild or above symptoms.

Exclusion Criteria:

  1. Does not meet the inclusion criteria listed above;
  2. Ovarian malignancy, ovarian or hysterectomy, premature ovarian failure, uterine fibroids ≥2 cm, severe breast hyperplasia;
  3. Acute gynecological infectious diseases or other acute infectious diseases;
  4. Severe liver or kidney dysfunction, or other serious systemic diseases;
  5. Use of hormonal drugs or traditional Chinese medicine for treatment in the past 2 months;
  6. Participation in other clinical trials;
  7. Patients who did not adhere to the treatment protocol or withdrew from the trial;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Placebo
Drug: Placebo
Placebo
Experimental: Jinfeng Pill group
Jinfeng Pill
Drug: Jinfeng Pill
Jinfeng Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week -1, Week 0, Week 4, Week 8, Week 12, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hot flash scale (HFs)
Time Frame: Week -1, Week 0, Week 4, Week 8, Week 12, Week 16
The severity of hot flash was evaluated using visual analog scale (0-10).The higher the value, the more severe the symptoms.
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
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.
Week 0, Week 12, Week 16
Hamilton depressive scale (HAMD)
Time Frame: Week 0, Week 12, Week 16
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.
Week 0, Week 12, Week 16
Hamilton anxiety scale (HAMA)
Time Frame: Week 0, Week 12, Week 16
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.
Week 0, Week 12, Week 16
Vaginal Health Index (VHI)
Time Frame: Week 0, Week 12
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.
Week 0, Week 12
TCM Syndrome Score Scale
Time Frame: Week 0, Week 12
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.
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 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).
Week 0, Week 12
Serum inflammatory factors (IL-6, TNF-α)
Time Frame: Week 0, Week 12
Serum concentrations of interleukin-6 (IL-6) and tumour necrosis factor-alpha (TNF-α) will be measured by ELISA
Week 0, Week 12
Intestinal microbiota β-GUS enzyme activity
Time Frame: Week 0, Week 12
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.
Week 0, Week 12
Short-Chain Fatty Acids (SCFAs)
Time Frame: Week 0, Week 12
Faecal concentrations of acetic acid, propionic acid, and butyric acid will be determined by gas chromatography.
Week 0, Week 12
Gut Microbiota Analysis
Time Frame: Week 0, Week 12
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.
Week 0, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TJ-IRB202512083

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Protecting participant privacy and data security.To consider potential data needs, please contact authorized researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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