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

2 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

320

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studiekontakt

  • Namn: Zhenzhen Feng, Doctor
  • Telefonnummer: 15890658268
  • E-post: huxifzz@163.com

Studieorter

  • Kina
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • First Affiliated Hospital of Henan University of Traditional Chinese Medicine
        • 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

18 år till 79 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

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
Experimentell: 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.
Läkemedel: 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-jämförare: 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.
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
28-Day All-Cause Mortality
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

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

Sponsor

Henan University of Traditional Chinese Medicine

Utredare

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

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)

2 november 2026

Primärt slutförande (Beräknad)

31 december 2029

Avslutad studie (Beräknad)

31 december 2029

Studieregistreringsdatum

Först inskickad

29 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

2 november 2026

Första postat (Faktisk)

6 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026-Sepsis-RCT

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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