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Status unknownNCT05265130Updated Mar 3, 2022

The Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis

A Phase 4 interventional study of YiQiFuMai and 0.9% Normal Saline 250ml in Sepsis, sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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 YQFM is proved to be effective for treating sepsis (unpublished data).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.

02

Conditions studied

  • Sepsis

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03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 80 is below the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 41 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    YQFM group

    YQFM 5.2g in 0.9% Normal Saline 250ml IV, about 40 drops per min, once a day.

    Drug: YiQiFuMai

  • Placebo comparator
    Placebo group

    0.9% Normal Saline 250ml IV, about 40 drops per min.

    Drug: 0.9% Normal Saline 250ml

Interventions

  • DrugYiQiFuMai

    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.

  • Drug0.9% Normal Saline 250ml

    0.9% Normal Saline 250ml IV, about 40 drops per min.

06

What researchers measure

Primary outcomes

  1. All-cause Mortality [28 days after randomization]

    Death from all causes at 28-days

    Time frame: In 28 days after randomization

  2. Mortality in ICU and several time points

    Death from all causes at ICU discharge, 7 days, and 14 days after randomization

    Time frame: In 14 days after randomization

  3. The secondary infection rate in 28 days.

    Time frame: In 28 days after randomization

  4. Length of stay in ICU

    Time frame: up to 28 days after randomization

  5. Absolute lymphocyte count in the routine blood test (*10^9g/L)

    Time frame: Change from baseline at 14 days after randomization

  6. Concentration of T cells and B cells

    CD3+CD4-CD8-, CD3+CD4+CD8-, CD3+CD4-CD8+, CD3+CD4+CD8+, CD3+CD19-, CD3-CD19+, CD3+(CD16+CD56)+, CD3-(CD16+CD56)+ ,CD4+CD25+,CD4+CD25+CD127- (cells/uL)

    Time frame: Change from baseline at 14 days after randomization

  7. Concentration of inflammatory cytokines

    interleukin (IL) 1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-17, interferon (IFN) α, IFN-γ, and Tumor nuclear factor (TNF)-α. (pg/mL);

    Time frame: Change from baseline at 14 days after randomization

  8. Concentration of Procalcitonin

    Time frame: Change from baseline at 14 days after randomization

  9. Length of stay in hospital

    Time frame: up to 28 days after randomization

Secondary outcomes

  1. Duration of mechanical ventilation (MV) in ICU

    Time frame: up to 28 days after randomization

  2. Duration of continual renal replacement therapy (CRRT) in ICU

    Time frame: up to 28 days after randomization

  3. Duration of vasopressor drugs in ICU

    Time frame: up to 28 days after randomization

  4. Duration of fluid resuscitation in ICU

    Time frame: up to 28 days after randomization

  5. Total amount of fluid resuscitation (mL) in ICU

    Time frame: up to 28 days after randomization

  6. SOFA score

    Total Sequential Organ Failure Assessment (SOFA) score (0-24), higher values represent a worse outcome

    Time frame: Change from baseline at 14 days after randomization

  7. APACHEII

    Acute Physiology and Chronic Health Evaluation (include Acute physiology score, APS and age and Chronic physiology score, totally 0-71 Points)

    Time frame: change from baseline at 7 days after randomization

  8. Self-Rating Anxiety Scale (SAS) score

    Score range from 0 to 80, higher values represent a worse outcome

    Time frame: change from baseline at 28 days after randomization

  9. Self-Rating Depression Scale (SDS) score

    Score range from 0 to 80, higher values represent a worse outcome

    Time frame: change from Day 7 at 28 days after randomization

  10. Barthel score

    Score range from 0 to 100, higher values represent a better outcome

    Time frame: change from baseline at 28 days after randomization

  11. The mean artery pressure (MBP)

    Time frame: change from baseline at 7 days after randomization

  12. The worst heart rate

    Time frame: change from baseline at 7 days after randomization

  13. Concentration of serum lactate

    Time frame: change from baseline at 14 days after randomization

  14. The rate of lactate clearance

    (baseline lactate-lactate)/baseline lactate

    Time frame: change from baseline at 14 days after randomization

  15. The volume of urine output

    Time frame: change from baseline at 14 days after randomization

  16. Concentration of IgM, IgG, IgE (g/L) (blood)

    Time frame: change from baseline at 14 days after randomization

  17. Concentration of complement in serum (C3 and C4) (g/L)

    Time frame: change from baseline at 14 days after randomization

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05265130
Lead sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Responsible party
Anlu Wang, MD (Prof., Xiyuan Hospital of China Academy of Chinese Medical Sciences) — Principal investigator
First posted
Mar 3, 2022
Start date
Feb 28, 2022 (estimated)
Primary completion
Jan 31, 2024 (estimated)
Completion
Oct 31, 2024 (estimated)
Last update
Mar 3, 2022

Study contacts

An-lu Wang
Contact
wwanganlu@126.com
+8662835151
Zhixu Yang, Prof.
principal investigator · Xiyuan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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