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Integrated Medicine for Sepsis: An RCT With Phenotyping (IMSEP-RCT)

2. November 2026 aktualisiert von: Henan University of Traditional Chinese Medicine

Efficacy of Integrated Chinese and Western Medicine for Sepsis With Phenotypic Profiling: A Randomized Controlled Trial

This study aims to evaluate the clinical efficacy and safety of integrated traditional Chinese and Western medicine in the treatment of sepsis, explore its potential value in improving clinical outcomes, and provide high-quality clinical evidence for the integrated management of sepsis.In addition, blood samples will be collected for phenotyping and subsequent transcriptomic, proteomic, and metabolomic analyses.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of integrated traditional Chinese and Western medicine in patients with sepsis. By comparing primary and secondary clinical outcomes between the intervention and control groups, the study aims to assess the effects of integrated treatment on disease improvement and clinical outcomes in patients with sepsis and to provide high-quality evidence for its clinical application.Biospecimen Collection. Fasting venous blood samples will be collected at predefined time points for subsequent transcriptomic, proteomic, and metabolomic analyses.

Studientyp

Interventionell

Einschreibung (Geschätzt)

320

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Zhenzhen Feng, Doctor
  • Telefonnummer: 15890658268
  • E-Mail: huxifzz@163.com

Studienorte

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • First Affiliated Hospital of Henan University of Traditional Chinese Medicine
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 79 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Age ≥18 years and <80 years.
  2. Meeting the Sepsis-3.0 definition and diagnostic criteria for sepsis, with a Sequential Organ Failure Assessment (SOFA) score of 2-13.
  3. Patients with pulmonary infection or bloodstream infection.
  4. Meeting the diagnostic criteria for one of the following traditional Chinese medicine syndrome patterns: phlegm-heat obstructing the lung syndrome, exuberant heat-toxin syndrome, Yangming bowel excess syndrome, or stasis-toxin obstructing the collaterals syndrome.
  5. Written informed consent provided by the patient or the patient's legally authorized representative/family member.

Exclusion Criteria:

  1. Patients with trauma, including fractures, burns, hepatic rupture, splenic rupture, or other major traumatic injuries.
  2. Pregnant or breastfeeding women.
  3. Patients with severe underlying diseases, including unresectable malignancies, hematologic diseases, or human immunodeficiency virus (HIV) infection.
  4. Use of immunosuppressive therapy or receipt of organ transplantation within the previous 3 months.
  5. Severe hepatic or renal dysfunction, defined as a score ≥3 in the hepatic or renal component of the SOFA score.
  6. Participation in another interventional drug clinical trial within 1 month prior to enrollment.
  7. Known allergy or hypersensitivity to any of the study medications.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Standard Western Medicine Plus Syndrome-Differentiated Chinese Herbal Medicine

Participants will receive standard Western medical treatment for sepsis in combination with syndrome-differentiated Chinese herbal medicine according to the study protocol.
Arzneimittel: Syndrome-Differentiated Chinese Herbal Medicine

Participants will receive standard Western medical treatment for sepsis plus syndrome-differentiated Chinese herbal medicine. The herbal formula will be prescribed according to the participant's traditional Chinese medicine syndrome pattern: Qinghua Formula for phlegm-heat obstructing the lung syndrome (including Scutellaria baicalensis, Fritillaria thunbergii, Gardenia jasminoides, and other herbs); Qingjie Formula for exuberant heat-toxin syndrome (including Lonicera japonica, Gardenia jasminoides, Forsythia suspensa, and other herbs); Tonghe Formula for Yangming bowel excess syndrome (including Rheum palmatum, Magnolia officinalis, processed Citrus aurantium, and other herbs); and Jiehua Formula for stasis-toxin obstructing the collaterals syndrome (including Bubalus bubalis Cornu, Lonicera japonica, Forsythia suspensa, and other herbs).
Placebo-Komparator: Standard Western Medicine Plus Matching Placebo

Participants will receive standard Western medical treatment for sepsis in combination with a matching placebo of the syndrome-differentiated Chinese herbal medicine according to the study protocol.
Arzneimittel: Matching Placebo for Syndrome-Differentiated Chinese Herbal Medicine

Participants will receive standard Western medical treatment for sepsis plus a matching placebo corresponding to the syndrome-differentiated Chinese herbal medicine. The placebo is prepared using 5% of the corresponding herbal formulation and is designed to match the Chinese herbal granules in appearance, weight, color, and odor.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
28-Day All-Cause Mortality
Zeitfenster: Day 28 after enrollment

The proportion of participants who die from any cause within 28 days after enrollment.
Day 28 after enrollment
Sequential Organ Failure Assessment (SOFA) Score
Zeitfenster: Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment

The Sequential Organ Failure Assessment (SOFA) score will be used to assess dysfunction in six organ systems: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal function. The total score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction.
Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Zeitfenster: Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment

Disease severity will be assessed using the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. The total score ranges from 0 to 71, with higher scores indicating greater disease severity.
Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment
Length of ICU Stay
Zeitfenster: From ICU admission through hospital discharge or Day 28, whichever occurs first

The duration of ICU stay will be calculated in days from ICU admission to the first discharge from the ICU. For participants who are readmitted to the ICU, ICU readmission and the cumulative duration of ICU stay will also be recorded.
From ICU admission through hospital discharge or Day 28, whichever occurs first
Ventilator-Free Days Within 28 Days
Zeitfenster: From enrollment through Day 28

The number of days during the first 28 days after enrollment that a participant is alive and free from invasive mechanical ventilation will be calculated.
From enrollment through Day 28
ICU-Free Days Within 28 Days
Zeitfenster: From enrollment through Day 28

The number of days through Day 28 during which a participant is alive and remains outside the ICU after the first ICU discharge will be calculated.
From enrollment through Day 28
Time to Sustained Resolution of Fever
Zeitfenster: From enrollment through Day 28

The time from enrollment to normalization of body temperature sustained for more than 72 hours will be recorded. A transient reduction in body temperature following administration of antipyretic medication will not be considered sustained resolution of fever.
From enrollment through Day 28
Duration of Antimicrobial Therapy
Zeitfenster: From enrollment through hospital discharge or Day 28, whichever occurs first.

The cumulative duration of intravenous and/or oral antimicrobial therapy during hospitalization will be recorded in days.
From enrollment through hospital discharge or Day 28, whichever occurs first.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Henan University of Traditional Chinese Medicine

Ermittler

  • Studienstuhl: Jiansheng Li, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

2. November 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2029

Studienabschluss (Geschätzt)

31. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

29. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. November 2026

Zuerst gepostet (Tatsächlich)

6. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-Sepsis-RCT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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