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Observational Study of the Clinical Efficacy and Safety of lizi Compound Capsule (Decoction) in Patients With Acute Lung Injury Due to Sepsis

Observational Study of the Clinical Efficacy and Safety of lizi Compound Capsule (Decoction) in Patients With Acute Lung Injury Due to Sepsis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087268
Enrollment
Unknown
Registered
2024-07-24
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

sepsis acute lung injury, SALI

Interventions

Compound Folly Capsule Group:Oral Compound Poria capsules combined with conventional treatment
Placebo group:Oral placebo plus usual care

Sponsors

The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Age between 18 and 80; ? Meets the diagnostic criteria for sepsis (as defined by the Sepsis 3.0 guidelines from the Surviving Sepsis Campaign); ? Meets the diagnostic criteria for acute lung injury (as defined by the Berlin definition); ? Diagnosis by both traditional Chinese and Western medicine agreed upon by two guiding experts from the research team; ? The patient or family is informed and voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Incomplete records of laboratory examination and disease course information; (2) pregnant or lactating women; (3) Patients with other serious physical diseases, AIDS, malignant tumors and mental illness; (4) patients who receive only hospice care; (5) Congenital or acquired immunodeficiency; (6) Those who are participating in clinical trials of other drugs, and those who are known to be allergic to therapeutic drugs.

Design outcomes

Primary

MeasureTime frame
28-day mortality;90-day mortality;Comprehensive efficacy of the disease;TCM syndrome efficacy;Indicators of acute lung injury;Incidence of ARDS;

Secondary

MeasureTime frame
Venous blood markers;Arterial blood gas analysis;Indicators of organ dysfunction;Economic evaluation indicators;Indicators of immune function;Stool indicators;Lung imaging indicators;

Countries

China

Contacts

Public ContactHuang Ren

The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine

2686918245@qq.com+86 182 2976 3709

Outcome results

None listed

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