NCT05265130

The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis

Evaluation of Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis: a Single Center Randomized Controlled Pilot Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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 mortality has diminished with advances in intensive care management and goal-directed interventions, only to surge after "recovery" from acute events, which prompts a search for sepsis-induced alterations in immune function. When suffered from sepsis, patients may have evidence of hyper-inflammation and immunosuppression. There are no high-quality evidence examining the effect of intravenous (IV) immunoglobulins or other immune modulators on the outcomes of patients with sepsis or septic shock. YiQiFuMai Injection (YQFM) is a redeveloped preparation based on the traditional Chinese medicine formula Sheng-Mai-San, which is widely used in clinical practice in China, mainly for the microcirculatory disturbance-related diseases. YQFM is proved to be effective for treating sepsis (unpublished data). And several researches reveal that YQFM attenuates acute respiratory distress syndrome and lipopolysaccharide-induced microvascular disturbance in vitro. The purpose of this study is to explore the adjunctive treatment effect of YQFM to prognosis, immune dysfunction and organ dysfunction of sepsis.

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	YiQiFuMai	YQFM is a redeveloped preparation based on the traditional Chinese medicine formula Sheng-Mai-San, which is widely used in clinical practice in China, mainly for the microcirculatory disturbance-related diseases.
DRUG	0.9% Normal Saline 250ml	0.9% Normal Saline 250ml IV, about 40 drops per min.

Timeline

• Start date: 2022-02-28
• Primary completion: 2024-01-31
• Completion: 2024-10-31
• First posted: 2022-03-03
• Last updated: 2022-03-03