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

18 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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;

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebogrupp
Placebo
Läkemedel: Placebo
Placebo
Experimentell: Jinfeng Pill group
Jinfeng Pill
Läkemedel: Jinfeng Pill
Jinfeng Pill

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The modified Kupperman Index (KI)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hot flash scale (HFs)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tongji Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

10 maj 2026

Primärt slutförande (Beräknad)

1 maj 2028

Avslutad studie (Beräknad)

1 maj 2028

Studieregistreringsdatum

Först inskickad

13 maj 2026

Först inskickad som uppfyllde QC-kriterierna

18 maj 2026

Första postat (Faktisk)

26 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • TJ-IRB202512083

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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