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Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome

30 giugno 2026 aggiornato da: Nanjing First Hospital, Nanjing Medical University
This prospective, open-label, randomized controlled clinical trial aims to evaluate the clinical efficacy and safety of Jingfang Granules in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) with cold-dampness encumbering the spleen syndrome, and to explore its potential mechanisms of action. A total of 106 patients with IBS-D of cold-dampness encumbering the spleen syndrome are planned to be enrolled and randomly assigned to the experimental group and the control group, with 53 patients in each group. The treatment will last for 4 weeks, followed by a 12-week follow-up period. The primary outcome measure is the IBS Severity Scoring System (IBS-SSS). Secondary outcomes include the Traditional Chinese Medicine (TCM) syndrome score, the Bristol Stool Form Scale, patient-reported outcome (PRO) scales, the IBS Quality of Life (IBS-QOL) questionnaire, recurrence rate, and others. Exploratory measures, such as immune-inflammatory cytokines and biomarkers related to intestinal mucosal barrier function, will also be observed.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

106

Fase

  • Fase 3

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
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210006
        • Nanjing First Hospitai
        • 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
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Meet the Western medicine diagnostic criteria for diarrhea-predominant irritable bowel syndrome (IBS-D) (IBS symptoms lasting for at least 6 months, and meeting the Rome IV criteria in the past 3 months) and the traditional Chinese medicine diagnostic criteria for cold-dampness disturbing spleen syndrome;
  2. Aged between 18 and 65 years, with no gender restriction;
  3. Baseline IBS-SSS score ≥ 75;
  4. No use of any medication for irritable bowel syndrome for at least 1 week before entering treatment;
  5. Subjects are informed and voluntarily sign the informed consent form.

Exclusion Criteria:

  1. Patients with severe cardiovascular, respiratory, liver, kidney, or other major organ diseases, diabetes, tumors, hematopoietic system disorders, nervous system diseases, or psychiatric disorders;
  2. Patients with other organic digestive system diseases (e.g., peptic ulcer) or systemic diseases affecting gastrointestinal motility (e.g., hyperthyroidism, diabetes mellitus);
  3. Patients currently using or requiring continuous use of medications that may affect gastrointestinal function (e.g., antidiarrheals, antidepressants, anxiolytics, intestinal microbiota regulators, antibiotics, etc.);
  4. Patients who have taken antibiotics, steroids or other hormones, herbal preparations (including oral and intravenous), microecological preparations, or probiotics (such as yogurt) within the past 1 week;
  5. Patients who have previously undergone abdominal or anorectal surgery;
  6. Pregnant or breastfeeding women;
  7. Patients with a history of allergy to relevant drugs or severe food allergy;
  8. Patients who have participated in or are currently participating in other interventional clinical research studies within the past 3 months;
  9. Patients who refuse to enroll in the observation or have other unstable factors, such as failure to take medication as prescribed, or taking other medications that affect the evaluation of efficacy, leading to inability to determine treatment effects, or incomplete data.

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: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Treatment with Trimebutine Maleate Tablets
Control group: Oral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks.
Droga: Trimebutine Maleate Tablets
Oral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks.
Altri nomi:
  • Trimebutine Tablets
Sperimentale: Treatment with Jingfang Granules
Experimental group: Oral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks.
Droga: Jingfang Granules
Oral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Irritable Bowel Syndrome Severity Scoring System scale
Lasso di tempo: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
This scale is an internationally recognized assessment tool for IBS symptom severity, with a total score ranging from 0 to 500. Lower scores indicate milder symptoms.
before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Biomarker
Lasso di tempo: before treatment, after 4 weeks of treatment
Measure the levels of biomarkers such as IL-1β, IFN-γ, IL-6, TNF-α, diamine oxidase, D-lactic acid, and endotoxin to explore the mechanism of action.
before treatment, after 4 weeks of treatment
Evaluation of the efficacy of Chinese medicine evidence
Lasso di tempo: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
A quantitative scale formulated based on the Guiding Principles for Clinical Research of New Chinese Medicines and the diagnostic criteria for cold-dampness encumbering the spleen pattern, with graded scoring for primary and secondary symptoms. Lower scores indicate milder syndromes.
before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
Patient-Reported Outcome scale
Lasso di tempo: before treatment, after 4 weeks of treatment
Assesses patients' self-perceived severity of core symptoms such as abdominal discomfort and bloating.
before treatment, after 4 weeks of treatment
Irritable Bowel Syndrome Quality of Life scale
Lasso di tempo: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
Assesses the quality of life of patients with IBS.
before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Lasso di tempo: Baseline (before treatment) to Week 4
Treatment-emergent adverse events (TEAEs) will be assessed throughout the study period based on spontaneous subject reports, physical examinations, and investigator observations. Incidence, severity (graded according to CTCAE v5.0), and relationship to study treatment will be recorded. The unit of measure for this outcome is the count of participants experiencing at least one TEAE.
Baseline (before treatment) to Week 4
Number of Participants with Clinically Significant Abnormalities in Safety Assessments
Lasso di tempo: Baseline (before treatment) to Week 4
Safety assessments include vital signs (temperature, respiratory rate, heart rate, and blood pressure), clinical laboratory tests (hematology, blood biochemistry, urinalysis, and stool examination), and 12-lead electrocardiography (ECG). The number of participants with at least one clinically significant abnormal finding according to protocol-defined clinical significance criteria will be reported. The unit of measure for this outcome is the count of participants; participants with multiple abnormal findings will be counted only once for this measure.
Baseline (before treatment) to Week 4
Bristol Stool Form scale
Lasso di tempo: before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment
Assesses stool form, classified into types 1 to 7. The mean daily BSFS score recorded on diary cards during the treatment period, and the typical BSFS type at each visit time point will be recorded.
before treatment, after 4 weeks of treatment, and 12 weeks after the end of treatment

Collaboratori e investigatori

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

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)

1 luglio 2026

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 febbraio 2028

Date di iscrizione allo studio

Primo inviato

17 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 giugno 2026

Primo Inserito (Effettivo)

7 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KY20260402-10

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

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 .

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