Clinical trial NCT06933238: Efficacy of Fuzheng Tongfu Jiedu Prescription for Treating Gastrointestinal Dysfunction Associated With Sepsis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Sepsis Abdominal
Gastrointestinal Dysfunction
Traditional Chinese Medicine
Keywords: gastrointestinal dysfunction
sepsis
Traditional Chinese medicine
Fuzheng Tongfu Jiedu Decoction
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing University of Chinese Medicine
First posted: 2025-04-18
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III.
2. 50-90 years old, regardless of gender.
3. Sequential Organ Failure Assessment (SOFA) score ≥ 2.
4. Diagnosed with sepsis-induced gastrointestinal dysfunction within 24 hours.
5. Voluntary participation with signed informed consent.

Exclusion Criteria:

1. ICU length of stay ≤ 3 days (due to death, discharge, or transfer), rendering gastrointestinal function evaluation unfeasible.
2. Patients with allergies or allergic constitution to the investigational herbal medications.
3. Inability to measure intra-abdominal pressure or abdominal circumference due to obesity (weight \> 150 kg), trauma, or surgical factors.
4. Severe organic diseases: lower gastrointestinal bleeding, malignancies, cirrhosis, chronic renal failure (uremic stage), hematologic disorders, HIV, etc.
5. History of gastrointestinal surgery.
6. Long-term use of corticosteroids or immunosuppressants.
7. Severe psychiatric disorders or inability to cooperate with trial protocols.
8. Participation in other clinical trials within 30 days.
9. Pregnant or lactating women.
10. Participated in other clinical studies in the past 3 months.

Primary outcomes:
measure: AGI grade
timeFrame: Day0, Day3,Day7,Day14
Secondary outcomes:
measure: Gastrointestinal symptoms score
timeFrame: Day0, Day3,Day7,Day14
measure: Abdominal pressure
timeFrame: Day0, Day3,Day7,Day14
measure: Abdominal circumference
timeFrame: Day0, Day3,Day7,Day14
measure: Blood routine
timeFrame: Day0, Day3,Day7,Day14
measure: CRP
timeFrame: Day0, Day3,Day7,Day14
measure: PCT
timeFrame: Day0, Day3,Day7,Day14
measure: Immune index-T cell functional subsets
timeFrame: Day0,Day7
measure: Immune index-lymphocyte subsets
timeFrame: Day0, Day7
measure: Intestinal barrier function-diamine oxidase（DAO）
timeFrame: Day0, Day7
measure: Intestinal barrier function-D-lactic acid level
timeFrame: Day0, Day7
measure: Intestinal barrier function--intestinal type Fatty acid Binding Protein (FABP)
timeFrame: Day0、 Day7
measure: Intestinal barrier function-Citrulline (CIT)
timeFrame: Day0、 Day7
measure: Severity of sepsis-SOFA score
timeFrame: Day0、 Day3、Day7、Day14
measure: Severity of sepsis-APACHE Ⅱ
timeFrame: Day0、 Day3、Day7、Day14
measure: Length of ICU stay
timeFrame: Day28
measure: 28-day mortality
timeFrame: Day28
Other outcomes:
measure: Safety index-Blood routine
timeFrame: Day0、 Day3、Day7、Day14
measure: Safety index-liver function
timeFrame: Day0、 Day3、Day7、Day14
measure: Safety index-Renal function
timeFrame: Day0、 Day3、Day7、Day14
measure: Safety index-Stool routine
timeFrame: Day0、 Day3、Day7、Day14
measure: Adverse event
timeFrame: Record any abnormality during the intervention.
measure: Mechanism discussion-mtDNA
timeFrame: Day0、 Day7
measure: Mechanism discussion-NLRP3
timeFrame: Day0、 Day7
measure: IL-1β
timeFrame: Day0、 Day7
measure: IL-18
timeFrame: Day0、 Day7
measure: IL-17
timeFrame: Day0、 Day7
Locations:
city: BeiJing
country: China
facility: Ethics Committee of Dongzhimen Hospital
state: Beijing
Study officials:
affiliation: ICU Dongzhimen Hospital
name: Jin Liu, Dr
role: STUDY_CHAIR
References: