Status:
RECRUITING
Evidence-based Evaluation and Mechanism of Shenhuang Granules in the Treatment of Sepsis
Lead Sponsor:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Collaborating Sponsors:
Zhejiang University
Red Cross Hospital, Hangzhou, China
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Sepsis is a life-threatening organ dysfunction caused by the body's dysfunctional response to infection, most patients require treatment in the ICU, and is the leading cause of death worldwide. Over t...
Detailed Description
1. Baseline data: patient's name, gender, age, enrollment diagnosis, sepsis diagnosis time, combined underlying disease, allergy history, personal history, body temperature, respiration, heart rate, b...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- Meet the diagnostic criteria of sepsis 3.0 guidelines
- Sign informed consent.
Exclusion
- Liver or kidney single SOFA score ≥3 points of liver and kidney dysfunction
- Death is expected within 48 hours, or SOFA≥15 points, or APACHE II ≥30 points, or the patient refuses active treatment
- Patients with allergic reactions to traditional Chinese medicine
- Patients treated with chemotherapy or radiotherapy or high-dose immunosuppressants within the last 1 month
- Participants in other clinical trials at the same time or within 30 days
- Pregnant and lactating women
- Patients with severe gastrointestinal bleeding, intestinal obstruction, or severe intraperitoneal pressure elevation (IAP≥20mmHg).
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT06514339
Start Date
July 1 2024
End Date
July 1 2026
Last Update
August 22 2025
Active Locations (1)
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1
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310006