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Yiqi Huoxue Granules for Elder Pulmonary Sepsis Patients: A Protocol of a Randomized Double-blinded Clinical study

Yiqi Huoxue Granules for Elder Pulmonary Sepsis Patients: A Protocol of a Randomized Double-blinded Clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000044
Enrollment
Unknown
Registered
2024-04-09
Start date
2023-10-17
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

sepsis

Interventions

Control Group(Western medicine conventional treatment plus Yiqi Huoxue placebo granule)):The conventional treatment of Western medicine plus placebo, which is based on the 2016 Sepsis 3.0 guidelines,

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Meet the definition and diagnostic criteria of sepsis 3.0: refer to the definition and diagnostic criteria of sepsis 3.0 jointly issued by the American Society of Critical Care Medicine (SCCM) and the European Society of Critical Care Medicine (ESICM) in 2016: there is a definite or suspected infection, and the SOFA score is = 2. (2) Meet the diagnostic criteria for pneumonia: community-acquired pneumonia: refer to the 2016 Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Chinese Adults, hospital-acquired pneumonia: refer to the 2018 Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia in Chinese Adults, and the source of sepsis infection is pneumonia; (3) invasive mechanical ventilation therapy; (4) Age = 65 years old and = 85 years old; Gender is not limited; (5) Those who signed informed consent

Exclusion criteria

Exclusion criteria: (1) Those who are in a dying state and may die within 24 hours; (2) Those with serious conditions requiring cardiopulmonary resuscitation; (3) Those with cachexia in advanced malignant tumors; (4) Those with acute coronary artery disease, such as acute myocardial infarction; (5) Those who are allergic to the taste of traditional Chinese medicine prescribed for Yiqi Huoxue granule, or those who are allergic to constitution; (6) pregnant or lactating women; (7) Those who have participated in other clinical trials in the past 3 months. (8) Other circumstances that the clinical investigator deems inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Invasive mechanical ventilation duration;

Secondary

MeasureTime frame
CD14+/HLA-DR;Sepsis-related Organ Failure Assessment score;PD-L1;oxygenation index;7 day case fatality rate;Number of days in 28 days not requiring ventilator support; Length of stay in ICU;Hospitalization days;Quick Sepsis-related Organ Failure Assessment score;WBC (white blood cell);PD-1;APACHE? score;

Countries

China

Contacts

Public ContactLi Jun

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine,

20222110158@stu.gzucm.edu.cn18823739106

Outcome results

None listed

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