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

Dongzhimen Hospital, Beijing

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Traditional Chinese Medicine; Gastrointestinal Dysfunction; Sepsis Abdominal

Treatments: Drug: Fuzheng Tongfu Jiedu prescription (FZTFJD); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06933238

DZMG-QNZX-24008

Details and patient eligibility

About

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

Full 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 treatment. Participants included in this study are diagnosed with sepsis-induced gastrointestinal dysfunction classified as Acute gastrointestinal injury (AGI)grades I-III. A total of seventy patients will be randomly assigned in a 1:1 ratio to receive either FZTFJD or placebo. The study encompasses a treatment duration of seven days followed by a twenty-one-day safety follow-up period. The AGI grade as the primary outcome measure will be assessed, while gut symptom score, abdominal pressure and circumference, SOFA and APACHE II scores, inflammation level as well as intestinal barrier function will serve as secondary outcome measures. Additionally, length of ICU stay and 28-day mortality will be included as prognostic indicators in this study.

Enrollment: 70 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Fuzheng Tongfu Jiedu prescription (FZTFJD)

Experimental group

Description:

Basic treatment + Fuzheng Tongfu Jiedu prescription

Treatment:

Drug: Fuzheng Tongfu Jiedu prescription (FZTFJD)

Placebo

Placebo Comparator group

Description:

Basic treatment + Fuzheng Tongfu Jiedu prescription placebo

Treatment:

Drug: Placebo