The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis

• Status: Not yet recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

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 sepsis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.