SepsisIMSEP-RCTNCT07920692
Integrated Medicine for Sepsis: An RCT With Phenotyping
A study testing Syndrome-Differentiated Chinese Herbal Medicine in people with Sepsis, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Syndrome-Differentiated Chinese Herbal Medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and <80 years.
- Meeting the Sepsis-3.0 definition and diagnostic criteria for sepsis, with a Sequential Organ Failure Assessment (SOFA) score of 2-13.
- Patients with pulmonary infection or bloodstream infection.
- 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.
- Written informed consent provided by the patient or the patient's legally authorized representative/family member.
Who cannot join
- Patients with trauma, including fractures, burns, hepatic rupture, splenic rupture, or other major traumatic injuries.
- Pregnant or breastfeeding women.
- Patients with severe underlying diseases, including unresectable malignancies, hematologic diseases, or human immunodeficiency virus (HIV) infection.
- Use of immunosuppressive therapy or receipt of organ transplantation within the previous 3 months.
- Severe hepatic or renal dysfunction, defined as a score ≥3 in the hepatic or renal component of the SOFA score.
- Participation in another interventional drug clinical trial within 1 month prior to enrollment.
- Known allergy or hypersensitivity to any of the study medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Zhenzhen Feng, Doctor, 15890658268, huxifzz@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Syndrome-Differentiated Chinese Herbal Medicine, Matching Placebo for Syndrome-Differentiated Chinese Herbal Medicine
- Keywords
- Sepsis, Integrated Traditional Chinese and Western Medicine, Traditional Chinese Medicine, Randomized Controlled Trial
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syndrome-Differentiated Chinese Herbal MedicineDrug
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).
Matching Placebo for Syndrome-Differentiated Chinese Herbal MedicineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Western Medicine Plus Syndrome-Differentiated Chinese Herbal Medicine | Experimental | Participants will receive standard Western medical treatment for sepsis in combination with syndrome-differentiated Chinese herbal medicine according to the study protocol. Receives: Drug: Syndrome-Differentiated Chinese Herbal Medicine |
| Standard Western Medicine Plus Matching Placebo | Placebo comparator | 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. Receives: Drug: Matching Placebo for Syndrome-Differentiated Chinese Herbal Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day All-Cause Mortality
The proportion of participants who die from any cause within 28 days after enrollment.
Measured: 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.
Measured: Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment through hospital discharge or Day 28, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiansheng Li, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920692
- Sponsor's protocol ID
- 2026-Sepsis-RCT
- Acronym
- IMSEP-RCT
- Status last verified
- Nov 2026
- First submitted
- 29 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Integrated Chinese and Western Medicine for Sepsis With Phenotypic Profiling: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07920692
- Acronym / sponsor ID
- IMSEP-RCT / 2026-Sepsis-RCT
- Conditions
- Sepsis
- Keywords
- Sepsis, Integrated Traditional Chinese and Western Medicine, Traditional Chinese Medicine, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Western Medicine Plus Syndrome-Differentiated Chinese Herbal Medicine | Experimental | Drug: Syndrome-Differentiated Chinese Herbal MedicineParticipants will receive standard Western medical treatment for sepsis in combination with syndrome-differentiated Chinese herbal medicine according to the study protocol. |
| Standard Western Medicine Plus Matching Placebo | Placebo comparator | Drug: Matching Placebo for Syndrome-Differentiated Chinese Herbal MedicineParticipants 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years and <80 years.
- Meeting the Sepsis-3.0 definition and diagnostic criteria for sepsis, with a Sequential Organ Failure Assessment (SOFA) score of 2-13.
- Patients with pulmonary infection or bloodstream infection.
- 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.
- Written informed consent provided by the patient or the patient's legally authorized representative/family member.
Key exclusion criteria (7 listed)
- Patients with trauma, including fractures, burns, hepatic rupture, splenic rupture, or other major traumatic injuries.
- Pregnant or breastfeeding women.
- Patients with severe underlying diseases, including unresectable malignancies, hematologic diseases, or human immunodeficiency virus (HIV) infection.
- Use of immunosuppressive therapy or receipt of organ transplantation within the previous 3 months.
- Severe hepatic or renal dysfunction, defined as a score ≥3 in the hepatic or renal component of the SOFA score.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syndrome-Differentiated Chinese Herbal MedicineParticipants 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). | Drug | Standard Western Medicine Plus Syndrome-Differentiated Chinese Herbal Medicine |
| Matching Placebo for Syndrome-Differentiated Chinese Herbal MedicineParticipants 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. | Drug | Standard Western Medicine Plus Matching Placebo |
Primary outcome
28-Day All-Cause Mortality
Time frame: Day 28 after enrollment
The proportion of participants who die from any cause within 28 days after enrollment.
Sequential Organ Failure Assessment (SOFA) Score
Time frame: 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.
6 secondary outcomes
Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Time frame: Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment
Length of ICU Stay
Time frame: From ICU admission through hospital discharge or Day 28, whichever occurs first
Ventilator-Free Days Within 28 Days
Time frame: From enrollment through Day 28
ICU-Free Days Within 28 Days
Time frame: From enrollment through Day 28
Time to Sustained Resolution of Fever
Time frame: From enrollment through Day 28
Duration of Antimicrobial Therapy
Time frame: From enrollment through hospital discharge or Day 28, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Related trials for Sepsis
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A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
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CT for Personalized Mechanical Ventilation
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiansheng Li study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syndrome-Differentiated Chinese Herbal Medicine in people with Sepsis, run by Henan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Feng, Doctor (15890658268, huxifzz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day All-Cause Mortality (time frame: Day 28 after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.