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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-90
SponsorDongzhimen Hospital, Beijing

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Fuzheng Tongfu Jiedu prescription (FZTFJD)
  • Placebo

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dongzhimen Hospital, Beijing

Lead sponsor

Beijing University of Chinese Medicine

Collaborator