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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis
• Intervention / Treatment: Drug: Syndrome-Differentiated Chinese Herbal Medicine; Drug: Matching Placebo for Syndrome-Differentiated Chinese Herbal Medicine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhenzhen Feng, Doctor; Phone Number: 15890658268; Email: huxifzz@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • First Affiliated Hospital of Henan University of Traditional Chinese Medicine
      • Contact: Zhenzhen Feng, Doctor; Phone Number: 15890658268; Email: huxifzz@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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 Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-Day All-Cause Mortality	The proportion of participants who die from any cause within 28 days after enrollment.	Day 28 after enrollment
Sequential Organ Failure Assessment (SOFA) Score	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Physiology and Chronic Health Evaluation II (APACHE II) Score	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	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	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	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	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	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.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Investigators: Study Chair: Jiansheng Li, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: October 29, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Sepsis; Traditional Chinese Medicine; Integrated Traditional Chinese and Western Medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: 2026-Sepsis-RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No