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

NCT06933238 | Not Yet Recruiting Phase 1

• 1 other identifier: DZMG-QNZX-24008
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sepsis Abdominal; Gastrointestinal Dysfunction; Traditional Chinese Medicine

Keywords

gastrointestinal dysfunction; sepsis; Traditional Chinese medicine; Fuzheng Tongfu Jiedu Decoction

Outcome Measures

Primary Outcomes (1)

• AGI grade

  As a predictor of mortality in critically ill patients, AGI grade is useful for identifying the severity of GI dysfunction. AGI grade refers to the diagnostic criteria for acute gastrointestinal injury established by the European Critical Care Society in 2012. AGI can be graded from a minimum of I to a maximum of IV. The higher the level, the more severe the gastrointestinal dysfunctionHigher AGI grade levels indicate progressively more severe conditions.

  Day0, Day3,Day7,Day14

Secondary Outcomes (16)

• Gastrointestinal symptoms score

  Day0, Day3,Day7,Day14

• Abdominal pressure

  Day0, Day3,Day7,Day14

• Abdominal circumference

  Day0, Day3,Day7,Day14

• Blood routine

  Day0, Day3,Day7,Day14

• CRP

  Day0, Day3,Day7,Day14

Other Outcomes (10)

• Safety index-Blood routine

  Day0、 Day3、Day7、Day14

• Safety index-liver function

  Day0、 Day3、Day7、Day14

• Safety index-Renal function

  Day0、 Day3、Day7、Day14

Study Arms (2)

Fuzheng Tongfu Jiedu prescription (FZTFJD)

EXPERIMENTAL

Basic treatment + Fuzheng Tongfu Jiedu prescription

Drug: Fuzheng Tongfu Jiedu prescription (FZTFJD)

Placebo

PLACEBO COMPARATOR

Basic treatment + Fuzheng Tongfu Jiedu prescription placebo

Drug: Placebo

Interventions

Fuzheng Tongfu Jiedu prescription (FZTFJD) 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.

Also known as: Conventional Western medical treatment

Fuzheng Tongfu Jiedu prescription (FZTFJD)

Placebo 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.

Also known as: Conventional Western medical treatment

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of sepsis-induced gastrointestinal dysfunction with Acute AGI grade I-III.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead
• Beijing University of Chinese Medicine: collaborator

Study Sites (1)

Ethics Committee of Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

Location

MeSH Terms

Conditions

Intraabdominal Infections; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin Liu, Dr

  ICU Dongzhimen Hospital

  STUDY CHAIR

Central Study Contacts

Xue ting Han

CONTACT

+86-01084012709; 529607340@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Both groups received 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.The experimental group additionally received Fuzheng Tongfu Jiedu prescription, a kind of traditional Chinese medicine (TCM) formula.On the basis of conventional Western medicine treatment, the control group received a placebo of the Fuzheng Tongfu Jiedu prescription.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 18, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Six months after the end of the study
• Access Criteria: ljhly05@163.com

Locations

CN (1)