Jinhong Deoction in the treatment of sepsis based on Truncating and Reversing method: a multicenter randomized controlled clinical trial
Phase 1
Recruiting
- Conditions
- Sepsis
- Registration Number
- ITMCTR2000003024
- Lead Sponsor
- onghua Hospital Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Aged 18-85 years.
2. Meet the diagnostic criteria of Sepsis 3.0 (The Third International Consensus Definition for Sepsis and Septic Shock).
3. Have Sequential Organ Failure Assessment (SOFA) score >= 2.
4. Provide signed informed consent form.
Exclusion Criteria
1. Allergy to traditional Chinese medicine or allergy constitution;
2. Severe primary disease including malignant tumor, severe liver and kidney dysfunction, blood diseases and Human Immunodeficiency Virus (HIV);
3. Using hormones or immunosuppressants for a long time;
4. Suffer from severe mental illness or unable to participate in the trial;
5. Participating in other clinical trials in the previous 30 days;
6. Pregnant and lactating women.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SOFA score;28-day mortality;
- Secondary Outcome Measures
Name Time Method major organ function;vital signs;60-day mortality;hospital costs and hospital stay;the marker of oxidative stress;inflammatory biomarkers;traditional Chinese medicine Syndrome Score;