Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

18 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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;

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Gruppo placebo
Placebo
Droga: Placebo
Placebo
Sperimentale: Jinfeng Pill group
Jinfeng Pill
Droga: Jinfeng Pill
Jinfeng Pill

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The modified Kupperman Index (KI)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hot flash scale (HFs)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tongji Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

10 maggio 2026

Completamento primario (Stimato)

1 maggio 2028

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

13 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • TJ-IRB202512083

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Italy

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi