Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

30. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

106

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210006
        • Nanjing First Hospitai
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: Trimebutine Maleate Tablets
Oral administration of Trimebutine Maleate Tablets, 100 mg per tablet, one tablet each time, three times daily, for 4 weeks.
Andre navne:
  • Trimebutine Tablets
Eksperimentel: 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.
Medicin: Jingfang Granules
Oral administration of Jingfang Granules, 15 g per sachet, one sachet each time, three times daily, for 4 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Irritable Bowel Syndrome Severity Scoring System scale
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biomarker
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. februar 2028

Datoer for studieregistrering

Først indsendt

17. juni 2026

Først indsendt, der opfyldte QC-kriterier

30. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY20260402-10

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diarré-dominerende irritabel tyktarm

Kliniske forsøg med Trimebutine Maleate Tablets

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sri Lanka

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner