Not Yet RecruitingPhase 1/2

Efficacy of Fuzheng Tongfu Jiedu Prescription for Treating Gastrointestinal Dysfunction Associated With Sepsis

China70 participantsStarted 2025-04-25

Plain-language summary

This study is a single-center, randomized, double-blind, placebo-controlled trial.

Age range50 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

AGI grade

Timeframe: Day0, Day3,Day7,Day14

NCT IDNCT06933238

SponsorDongzhimen Hospital, Beijing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Xue ting Han