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Efficacy and Safety of Qiang-Ji-Jian-Li Formula in Patients with Sepsis-induced Myopathy: A Single-center Parallel Evaluator-Blinded Add-on Pragmatic Randomized Controlled Trial

Efficacy and Safety of Qiang-Ji-Jian-Li Formula in Patients with Sepsis-induced Myopathy: A Single-center Parallel Evaluator-Blinded Add-on Pragmatic Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000163
Enrollment
Unknown
Registered
2025-01-25
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis-induced Myopathy

Interventions

Experimental group:Basic treatment of Sepsis and Qiang-Ji-Jian-Li Formula
Control group:Basic treatment of Sepsis

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Participants must be aged between 18 and 85 years. 2. Participants must satisfy the diagnostic criteria for Sepsis 3.0. 3. Participants must fulfill the diagnostic criteria for Sepsis-induced Myopathy. 4. The patient or an immediate family member or legal representative must provide agreement and sign a written informed consent document.

Exclusion criteria

Exclusion criteria: 1. A confirmed pregnancy or the urine ß-HCG test is positive. 2. Newly identified primary neuromuscular disease upon admission. 3. Individuals who are unable to complete Rectus Femoris Cross-sectional Area measurements due to leg amputation pelvic or femoral fractures or knee or hip arthroplasty. 4. Patients diagnosed with Metastatic tumors (PD) or currently undergoing chemotherapy. 5. Patients who have received long-term treatment with oral corticosteroids. 6. Individuals who were unable to walk independently or with assistive devices prior to the onset of sepsis.

Design outcomes

Primary

MeasureTime frame
All-cause mortality in 28-day;All-cause mortality in 1-year;Rectus Femoris Cross-sectional Area;

Secondary

MeasureTime frame
Unplanned ICU readmission;Oxygen uptake rate;Pv-aCO2;Duration of prone ventilation;Duration of invasive/non-invasive mechanical ventilation;Unplanned hospital readmissions;Oxygen consumption index;Medical Research Council-Sum Score;Oxygen delivery index;Infection-related results;Duration of hospitalization in days;lactic acid; Duration of stay in the ICU;

Countries

China

Contacts

Public ContactWei-Tao Chen

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

chenweitao1900@gzucm.edu.cn+86 13924183501

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026