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

Launched by DONGZHIMEN HOSPITAL, BEIJING · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a traditional Chinese medicine treatment called Fuzheng Tongfu Jiedu Prescription to see how effective it is for patients experiencing gastrointestinal problems due to sepsis, a serious infection that can affect the whole body. The trial will involve adult participants aged between 50 and 90 years who have been diagnosed with sepsis-induced gastrointestinal dysfunction within the last 24 hours. To qualify, potential participants must have a specific level of organ function assessed by a scoring system, and they need to be willing to join the study and sign consent forms.

If someone is eligible and chooses to participate, they will be randomly assigned to receive either the herbal treatment or a placebo (a non-active treatment that looks the same) without knowing which one they are getting. The trial is designed to ensure that the results are unbiased. Participants can expect regular check-ups to monitor their health throughout the study. It's important to note that some individuals, such as those with certain serious health conditions or those who have had recent surgeries, may not be able to join the trial. This study is currently not recruiting participants yet, but it aims to better understand how this traditional treatment can help improve gastrointestinal function in patients with sepsis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III.
• • 2. 50-90 years old, regardless of gender.
• • 3. Sequential Organ Failure Assessment (SOFA) score ≥ 2.
• • 4. Diagnosed with sepsis-induced gastrointestinal dysfunction within 24 hours.
• • 5. Voluntary participation with signed informed consent.
• Exclusion Criteria:
• • 1. ICU length of stay ≤ 3 days (due to death, discharge, or transfer), rendering gastrointestinal function evaluation unfeasible.
• • 2. Patients with allergies or allergic constitution to the investigational herbal medications.
• • 3. Inability to measure intra-abdominal pressure or abdominal circumference due to obesity (weight \> 150 kg), trauma, or surgical factors.
• • 4. Severe organic diseases: lower gastrointestinal bleeding, malignancies, cirrhosis, chronic renal failure (uremic stage), hematologic disorders, HIV, etc.
• • 5. History of gastrointestinal surgery.
• • 6. Long-term use of corticosteroids or immunosuppressants.
• • 7. Severe psychiatric disorders or inability to cooperate with trial protocols.
• • 8. Participation in other clinical trials within 30 days.
• • 9. Pregnant or lactating women.
• • 10. Participated in other clinical studies in the past 3 months.