Status:
NOT_YET_RECRUITING
Efficacy of Fuzheng Tongfu Jiedu Prescription for Treating Gastrointestinal Dysfunction Associated With Sepsis
Lead Sponsor:
Dongzhimen Hospital, Beijing
Collaborating Sponsors:
Beijing University of Chinese Medicine
Conditions:
Sepsis Abdominal
Gastrointestinal Dysfunction
Eligibility:
All Genders
50-90 years
Phase:
PHASE1
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06933238
Start Date
April 25 2025
End Date
June 30 2026
Last Update
April 18 2025
Active Locations (1)
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1
Ethics Committee of Dongzhimen Hospital
Beijing, Beijing Municipality, China, 100700