An interventional study of Syndrome-Differentiated Chinese Herbal Medicine and Matching Placebo for Syndrome-Differentiated Chinese Herbal Medicine in Sepsis, sponsored by Henan University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Henan University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 320 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Henan University of Traditional Chinese Medicine is the lead sponsor of 55 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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).
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.
28-Day All-Cause Mortality
The proportion of participants who die from any cause within 28 days after enrollment.
Time frame: 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.
Time frame: Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment through hospital discharge or Day 28, whichever occurs first.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Henan University of Traditional Chinese Medicine