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The clinical effect and mechanism of Fuzheng Tongfu Jiedu prescription regulating cell pyrodeath in the treatment of gastrointestinal dysfunction in sepsis

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000938
Enrollment
Unknown
Registered
2025-05-09
Start date
2025-05-10
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Dysfunction Associated with Sepsis

Interventions

Observation group:Basic treatment + Fuzheng Tongfu Jiedu prescription
Control group:Basic treatment + Fuzheng Tongfu Jiedu prescription placebo

Sponsors

Dongzhimen Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) The diagnosis was consistent with sepsis-induced gastrointestinal dysfunction characterized by the TCM syndrome of deficiency in fu-organs with concurrent stasis of solid toxins. AGI grading was classified as Grade I-III; (2) Patients aged between 50 and 90 years inclusive of any gender; (3) SOFA score: =2 points; (4) Diagnosis of sepsis-induced gastrointestinal dysfunction within 24 hours; (5) Voluntary participation in this study with signed informed consent.

Exclusion criteria

Exclusion criteria: (1) The frequency of watery stool and diarrhea exceeds three times daily with a total volume greater than 1500 mL. (2) Changes in gastrointestinal function could not be evaluated due to ICU stays shorter than seven days (e.g. death discharge transfer out of ICU). (3) Abdominal pressure and circumference could not be measured in patients with excessive weight (weight > 150 kg) or those who have undergone trauma or surgery. (4) Patients with severe organic diseases including end-stage hematologic malignancies decompensated liver cirrhosis HIV and other serious underlying conditions that pose an imminent risk to life. (5) Patients who have undergone gastrointestinal surgery. (6) Patients on long-term use of hormones immunosuppressants or other medications. (7) Patients with severe psychiatric disorders or unable to participate in the study. (8) Participants who have enrolled in other clinical trials within the past 30 days. (9) Pregnant or lactating women. (10) Patients with allergies to traditional Ch

Design outcomes

Primary

MeasureTime frame
AGI classification;

Secondary

MeasureTime frame
FABP;T cell functional subsets detection;Lymphocyte subsets;PCT;CIT;TCM syndrome score;DAO;Gastrointestinal symptom score;abdomen circumference;Blood routine +CRP;Cytokine;SOFA score;Immune factor;Abdominal pressure;28-day mortality rate;D-lactic acid;APACHE ? score;ICU stay;

Countries

China

Contacts

Public ContactLIU Jin

Dongzhimen Hospital Beijing University of Chinese Medicine

ljhly05@163.com15011524279

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026