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

NCT ID: NCT06933238

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-25
• Study Completion Date: 2026-06-30

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 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.

Conditions

Sepsis Abdominal; Gastrointestinal Dysfunction; Traditional Chinese Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fuzheng Tongfu Jiedu prescription (FZTFJD)

Basic treatment + Fuzheng Tongfu Jiedu prescription

Group Type: EXPERIMENTAL

Fuzheng Tongfu Jiedu prescription (FZTFJD)

Intervention Type: DRUG

Fuzheng Tongfu Jiedu prescription (FZTFJD), a kind of Traditional Chinese medicine (TCM).Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.

Placebo

Basic treatment + Fuzheng Tongfu Jiedu prescription placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Fuzheng Tongfu Jiedu prescription plaebo. Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.

Interventions

Fuzheng Tongfu Jiedu prescription (FZTFJD)

Fuzheng Tongfu Jiedu prescription (FZTFJD), a kind of Traditional Chinese medicine (TCM).Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.

Intervention Type: DRUG

Placebo

Fuzheng Tongfu Jiedu prescription plaebo. Conventional Western medical treatment in accordance with the "2021 International Guidelines for the Management of Sepsis and Septic Shock." . This included treatment and resuscitation begin immediately, administering antimicrobials immediately, hemodynamic management, mechanical ventilation, organ support, nutritional support, and prophylaxis for acute ulcers.

Intervention Type: DRUG

Other Intervention Names

Conventional Western medical treatment; Conventional Western medical treatment

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing University of Chinese Medicine

OTHER

Sponsor Role: collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

ljhly05

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Liu, Dr

Role: STUDY_CHAIR

ICU Dongzhimen Hospital

Locations

Ethics Committee of Dongzhimen Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Xue ting Han

Role: CONTACT

529607340@qq.com

+86-01084012709

Other Identifiers

DZMG-QNZX-24008

Identifier Type: -

Identifier Source: org_study_id