Sepsis AbdominalPhase 1/2FZTFJDNCT06933238
Efficacy of Fuzheng Tongfu Jiedu Prescription for Treating Gastrointestinal Dysfunction Associated With Sepsis
A Phase 1/2 study testing Fuzheng Tongfu Jiedu prescription (FZTFJD) in people with Sepsis Abdominal and Gastrointestinal Dysfunction, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
This study is a single-center, randomized, double-blind, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Sepsis Abdominal, Gastrointestinal Dysfunction, Traditional Chinese Medicine
- What is being tested?
- Fuzheng Tongfu Jiedu prescription (FZTFJD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 30 Jun 2026
- Phase
- Phase 1/2
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III.
- 50-90 years old, regardless of gender.
- Sequential Organ Failure Assessment (SOFA) score ≥ 2.
- Diagnosed with sepsis-induced gastrointestinal dysfunction within 24 hours.
- Voluntary participation with signed informed consent.
Who cannot join
- ICU length of stay ≤ 3 days (due to death, discharge, or transfer), rendering gastrointestinal function evaluation unfeasible.
- Patients with allergies or allergic constitution to the investigational herbal medications.
- Inability to measure intra-abdominal pressure or abdominal circumference due to obesity (weight > 150 kg), trauma, or surgical factors.
- Severe organic diseases: lower gastrointestinal bleeding, malignancies, cirrhosis, chronic renal failure (uremic stage), hematologic disorders, HIV, etc.
- History of gastrointestinal surgery.
- Long-term use of corticosteroids or immunosuppressants.
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- Severe psychiatric disorders or inability to cooperate with trial protocols.
- Participation in other clinical trials within 30 days.
- Pregnant or lactating women.
- Participated in other clinical studies in the past 3 months.
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
Ethics Committee of Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
About this study
Official title: The Clinical Effect and Mechanism of Fuzheng Tongfu Jiedu Prescription Regulating Cell Pyrodeath in the Treatment of Gastrointestinal Dysfunction in Sepsis Based on mtDNA/NLRP3/Caspase-1/GSDMD Signaling Pathway
This study is a single-center, randomized, double-blind, placebo-controlled trial.
Read the detailed description
The study is designed to evaluate efficacy and safety of FZTFJD for treating gastrointestinal dysfunction associated with sepsis compared to placebo in combination with conventional western medicine treatment. Participants included in this study are diagnosed with sepsis-induced gastrointestinal dysfunction classified as Acute gastrointestinal injury (AGI)grades I-III. A total of seventy patients will be randomly assigned in a 1:1 ratio to receive either FZTFJD or placebo. The study encompasses a treatment duration of seven days followed by a twenty-one-day safety follow-up period. The AGI grade as the primary outcome measure will be assessed, while gut symptom score, abdominal pressure and circumference, SOFA and APACHE II scores, inflammation level as well as intestinal barrier function will serve as secondary outcome measures. Additionally, length of ICU stay and 28-day mortality will be included as prognostic indicators in this study.
- Being tested
- Fuzheng Tongfu Jiedu prescription (FZTFJD), Placebo
- Keywords
- gastrointestinal dysfunction, sepsis, Traditional Chinese medicine, Fuzheng Tongfu Jiedu Decoction
- Medical subject headings
- Intraabdominal Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzheng Tongfu Jiedu prescription (FZTFJD)Drug
Also called Conventional Western medical treatment
Fuzheng Tongfu Jiedu prescription (FZTFJD), a kind of Traditional Chinese medicine (TCM).Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.
PlaceboDrug
Also called Conventional Western medical treatment
Fuzheng Tongfu Jiedu prescription plaebo. Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.
| Study group | Role | What they receive |
|---|---|---|
| Fuzheng Tongfu Jiedu prescription (FZTFJD) | Experimental | Basic treatment + Fuzheng Tongfu Jiedu prescription Receives: Drug: Fuzheng Tongfu Jiedu prescription (FZTFJD) |
| Placebo | Placebo comparator | Basic treatment + Fuzheng Tongfu Jiedu prescription placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AGI grade
As a predictor of mortality in critically ill patients, AGI grade is useful for identifying the severity of GI dysfunction. AGI grade refers to the diagnostic criteria for acute gastrointestinal injury established by the European Critical Care Society in 2012. AGI can be graded from a minimum of I to a maximum of IV. The higher the level, the more severe the gastrointestinal dysfunctionHigher AGI grade levels indicate progressively more severe conditions.
Measured: Day0, Day3,Day7,Day14
Secondary outcomes (16)
Gastrointestinal symptoms score
The gastrointestinal symptoms score will be assessed by GSRS scale. The total score of the GSRS scale ranges from 0 to 78, with higher scores indicating more severe gastrointestinal symptoms.
Measured: Day0, Day3,Day7,Day14
Abdominal pressure
Abdominal pressure is measured by bladder pressure which is measured by water column method.Higher abdominal pressure levels indicate progressively more severe conditions.
Measured: Day0, Day3,Day7,Day14
Abdominal circumference
At the end of exhalation and before the beginning of inhalation, the abdominal circumference through the center of the umbilical cord was measured with a soft ruler.
Measured: Day0, Day3,Day7,Day14
Blood routine
Blood routine test will be determined by blood cell analyzer.White blood cells higher or lower than normal indicate a septic inflammatory state.
Measured: Day0, Day3,Day7,Day14
CRP
Expression levels of C-reactive proteins will be measured by Elida kit. The higher the level, the higher the sepsis inflammation.
Measured: Day0, Day3,Day7,Day14
PCT
Expression levels of Procalcitonin will be measured with a specific kit. The higher the level, the higher the sepsis inflammation.
Measured: Day0, Day3,Day7,Day14
Immune index-T cell functional subsets
The expression level of T cell functional subsets was detected
Measured: Day0,Day7
Immune index-lymphocyte subsets
The expression level of lymphocyte subsets was detected
Measured: Day0, Day7
Intestinal barrier function-diamine oxidase（DAO）
DAO is an important marker of intestinal mucosal integrity, and its activity level can reflect the strength of intestinal barrier function. When the gut is damaged, DAO is released into the blood, resulting in elevated DAO levels in the blood.The expression level of DAO in serum will be deteceed by the Eliasa kit.
Measured: Day0, Day7
Intestinal barrier function-D-lactic acid level
The expression level of serum D-lactic acid will be measured by a specific Elisa kit.
D-lactic acid is produced by bacteria in the gastrointestinal tract and then absorbed into the bloodstream. An increase of D-lactic acid indicates increased damage to the intestinal barrier and increased intestinal permeability in patients with sepsis.
Measured: Day0, Day7
Intestinal barrier function--intestinal type Fatty acid Binding Protein (FABP)
Serum midgut fatty acid-binding protein (I-FABP) expression levels will be detected by a specific elisa kit. I-FABP is located in the cytoplasm of mature intestinal cells in the small intestinal villi, and ischemia of the intestinal villi can release I-FABP into the blood circulation. The increase of I-FABP in serum indicates increased intestinal ischemia.
Measured: Day0、 Day7
Intestinal barrier function-Citrulline (CIT)
Since citrulline is mostly synthesized in intestinal mucosal epithelial cells, the number and function of intestinal mucosal epithelial cells can be evaluated by detecting the serum citrulline concentration. Therefore, monitoring the serum citrulline concentration can evaluate the intestinal function and the severity of intestinal dysfunction in critically ill patients.The expression level of CIT level in serum will be deteceed by the Eliasa kit.Since citrulline is mostly synthesized in intestinal mucosal epithelial cells, the number and function of intestinal mucosal epithelial cells can be evaluated by detecting the serum citrulline concentration. The decrease of serum citrulline level can reflect the decrease of intestinal mucosal epithelial cells.
Measured: Day0、 Day7
Severity of sepsis-SOFA score
The score of SOFA will be assessed according to the SOFA scale. The total SOFA score is derived by adding the scores of the six organ systems and ranges from 0 to 24 points. The higher the score, the more severe the patient's organ dysfunction and the worse the prognosis.
Measured: Day0、 Day3、Day7、Day14
Severity of sepsis-APACHE Ⅱ
The score of APACHE Ⅱ will be assessed according to the APACHE Ⅱ scale. The APACHEⅡ scoring system is composed of acute physiology score (APS), age score, and three parts. The final score is the sum of the three parts. The maximum theoretical score is 71, the higher the score, the more severe the disease.
Measured: Day0、 Day3、Day7、Day14
Length of ICU stay
The length of ICU stay is closely related to sepsis condition, prognosis and medical expenditure. The longer the ICU stay, the worse the prognosis and the higher the medical expenditure.
Measured: Day28
28-day mortality
The 28-day mortality rate intuitively reflects the prognosis of sepsis.
Measured: Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start25 Apr 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis AbdominalStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both groups received conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.The experimental group additionally received Fuzheng Tongfu Jiedu prescription, a kind of traditional Chinese medicine (TCM) formula.On the basis of conventional Western medicine treatment, the control group received a placebo of the Fuzheng Tongfu Jiedu prescription.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
- Responsible party
- Principal investigator, ljhly05, Dongzhimen Hospital, Beijing
- Investigators
- Jin Liu, Dr, Study chair, ICU Dongzhimen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933238
- Sponsor's protocol ID
- DZMG-QNZX-24008
- Acronym
- FZTFJD
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be shared with sleep researchers, public, and relevant academic institutions through high-impact peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect and Mechanism of Fuzheng Tongfu Jiedu Prescription Regulating Cell Pyrodeath in the Treatment of Gastrointestinal Dysfunction in Sepsis Based on mtDNA/NLRP3/Caspase-1/GSDMD Signaling Pathway
- ClinicalTrials.gov ID
- NCT06933238
- Acronym / sponsor ID
- FZTFJD / DZMG-QNZX-24008
- Keywords
- gastrointestinal dysfunction, sepsis, Traditional Chinese medicine, Fuzheng Tongfu Jiedu Decoction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Apr 2025 (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 is a single-center, randomized, double-blind, placebo-controlled trial.
Detailed description
The study is designed to evaluate efficacy and safety of FZTFJD for treating gastrointestinal dysfunction associated with sepsis compared to placebo in combination with conventional western medicine treatment. Participants included in this study are diagnosed with sepsis-induced gastrointestinal dysfunction classified as Acute gastrointestinal injury (AGI)grades I-III. A total of seventy patients will be randomly assigned in a 1:1 ratio to receive either FZTFJD or placebo. The study encompasses a treatment duration of seven days followed by a twenty-one-day safety follow-up period. The AGI grade as the primary outcome measure will be assessed, while gut symptom score, abdominal pressure and circumference, SOFA and APACHE II scores, inflammation level as well as intestinal barrier function will serve as secondary outcome measures. Additionally, length of ICU stay and 28-day mortality will be included as prognostic indicators in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Both groups received conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.The experimental group additionally received Fuzheng Tongfu Jiedu prescription, a kind of traditional Chinese medicine (TCM) formula.On the basis of conventional Western medicine treatment, the control group received a placebo of the Fuzheng Tongfu Jiedu prescription.
| Arm | Type | Receives |
|---|---|---|
| Fuzheng Tongfu Jiedu prescription (FZTFJD) | Experimental | Drug: Fuzheng Tongfu Jiedu prescription (FZTFJD)Basic treatment + Fuzheng Tongfu Jiedu prescription |
| Placebo | Placebo comparator | Drug: PlaceboBasic treatment + Fuzheng Tongfu Jiedu prescription placebo |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III.
- 50-90 years old, regardless of gender.
- Sequential Organ Failure Assessment (SOFA) score ≥ 2.
- Diagnosed with sepsis-induced gastrointestinal dysfunction within 24 hours.
- Voluntary participation with signed informed consent.
Key exclusion criteria (10 listed)
- ICU length of stay ≤ 3 days (due to death, discharge, or transfer), rendering gastrointestinal function evaluation unfeasible.
- Patients with allergies or allergic constitution to the investigational herbal medications.
- Inability to measure intra-abdominal pressure or abdominal circumference due to obesity (weight > 150 kg), trauma, or surgical factors.
- Severe organic diseases: lower gastrointestinal bleeding, malignancies, cirrhosis, chronic renal failure (uremic stage), hematologic disorders, HIV, etc.
- History of gastrointestinal surgery.
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 |
|---|---|---|
| Fuzheng Tongfu Jiedu prescription (FZTFJD)Also: Conventional Western medical treatmentFuzheng Tongfu Jiedu prescription (FZTFJD), a kind of Traditional Chinese medicine (TCM).Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers. | Drug | Fuzheng Tongfu Jiedu prescription (FZTFJD) |
| PlaceboAlso: Conventional Western medical treatmentFuzheng Tongfu Jiedu prescription plaebo. Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers. | Drug | Placebo |
Primary outcome
AGI grade
Time frame: Day0, Day3,Day7,Day14
As a predictor of mortality in critically ill patients, AGI grade is useful for identifying the severity of GI dysfunction. AGI grade refers to the diagnostic criteria for acute gastrointestinal injury established by the European Critical Care Society in 2012. AGI can be graded from a minimum of I to a maximum of IV. The higher the level, the more severe the gastrointestinal dysfunctionHigher AGI grade levels indicate progressively more severe conditions.
16 secondary outcomes
Gastrointestinal symptoms score
Time frame: Day0, Day3,Day7,Day14
Abdominal pressure
Time frame: Day0, Day3,Day7,Day14
Abdominal circumference
Time frame: Day0, Day3,Day7,Day14
Blood routine
Time frame: Day0, Day3,Day7,Day14
CRP
Time frame: Day0, Day3,Day7,Day14
PCT
Time frame: Day0, Day3,Day7,Day14
Immune index-T cell functional subsets
Time frame: Day0,Day7
Immune index-lymphocyte subsets
Time frame: Day0, Day7
Intestinal barrier function-diamine oxidase（DAO）
Time frame: Day0, Day7
Intestinal barrier function-D-lactic acid level
Time frame: Day0, Day7
Intestinal barrier function--intestinal type Fatty acid Binding Protein (FABP)
Time frame: Day0、 Day7
Intestinal barrier function-Citrulline (CIT)
Time frame: Day0、 Day7
Severity of sepsis-SOFA score
Time frame: Day0、 Day3、Day7、Day14
Severity of sepsis-APACHE Ⅱ
Time frame: Day0、 Day3、Day7、Day14
Length of ICU stay
Time frame: Day28
28-day mortality
Time frame: Day28
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 18 Apr 2025.
- Individual participant dataSharing planned: Yes. The results will be shared with sleep researchers, public, and relevant academic institutions through high-impact peer-reviewed publications.
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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.
Jin Liu, Dr study chair
ICU Dongzhimen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fuzheng Tongfu Jiedu prescription (FZTFJD) in people with Sepsis Abdominal and Gastrointestinal Dysfunction, run by Dongzhimen Hospital, Beijing 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 10 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 18 Apr 2025. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xue ting Han (+86-01084012709, 529607340@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AGI grade (time frame: Day0, Day3,Day7,Day14). 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 18 Apr 2025.