A randomized controlled trial for the traditional Chinese medicine Jinhong Decoction in the prevention and treatment of sepsis based on truncation and torsion strategy
Phase 1
- Conditions
- Sepsis
- Registration Number
- ITMCTR1900002275
- Lead Sponsor
- ongHua Hospital Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1) Aged 18 and 80 years;
2) Consistent with diagnostic criteria of International Guidelines for Management of Sepsis and Septic Shock: 2016;
3) APACHE II score<30;
4) To be able to and willing to provide signed informed consent.
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 28-days and 60-days Deaths;
- Secondary Outcome Measures
Name Time Method inflammatory biomarkers;major organ function;the marker of oxidative stress;traditional Chinese medicine Syndrome Score;SOFA score;the changes of intestinal flora;vital signs;hospital costs and hospital stay;