Efficacy of Fuzheng Tongfu Jiedu Prescription for Treating Gastrointestinal Dysfunction Associated With Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fuzheng Tongfu Jiedu prescription (FZTFJD), Placebo.
- Who it may be relevant to
- Registry conditions: Sepsis Abdominal, Gastrointestinal Dysfunction, Traditional Chinese Medicine. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Fuzheng Tongfu Jiedu prescription (FZTFJD)
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. - Drug Placebo
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.
Primary outcome measures
- AGI grade [Time frame: Day0, Day3,Day7,Day14]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ethics Committee of Dongzhimen Hospital — Beijing
Identifiers
NCT: NCT06933238 · DZMG-QNZX-24008