Status:
UNKNOWN
The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Conditions:
Sepsis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
This is a prospective single center pilot randomized controlled study to assess the efficacy and safety of YiQiFuMai injection (YQFM), a widely used Chinese medicine, as an adjunctive treatment for se...
Detailed Description
Sepsis is a major clinical challenge with high mortality and morbidity worldwide. Sepsis is characterized by the dysregulated host response to an infection followed by organ dysfunction. Early sepsis ...
Eligibility Criteria
Inclusion
- Sepsis defined by Sepsis-3 definition
- Adult patients between the ages of 18 and 90.
- Informed consent is provided by patients or obtained by family member if patient is incapacitated.
Exclusion
- Known severe allergic reaction to drugs including but not limited to YQFM.
- Pregnant patients or those who may be pregnant
- Patients with severe intracranial diseases (intracranial artery stenosis, intracranial infection, cerebral hemorrhage, cerebral infarction, brain trauma, subjects after intracranial surgery)
- Patients with extremely severe brain injury, after cardiopulmonary resuscitation, advanced malignant tumor, combined with serious primary diseases such as liver, lung, kidney and hematopoietic system, and poor prognosis;
- Autoimmune diseases, immune deficiency diseases, continuous use of immunosuppressants within the last 6 months, or organ transplants;
- Major surgery or trauma within the last 2 weeks;
- Participated in other clinical trials or took similar drugs within 1 month;
- The investigator considered that the subjects had poor compliance or other clinical, social, or family factors that were inappropriate for inclusion in the study.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05265130
Start Date
February 28 2022
End Date
October 31 2024
Last Update
March 3 2022
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