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Adaptive Platform Trial on Integrated Traditional Chinese and Western Medicine for Acute Respiratory Distress Syndrome

Adaptive Platform Trial on Integrated Traditional Chinese and Western Medicine for Acute Respiratory Distress Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000397
Enrollment
Unknown
Registered
2026-02-13
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Interventions

Experimental Group 1:Standard care + Fusu mixture
Experimental Group 2:Standard care + Tongfu Xiefei Formula

Sponsors

Chengdu University of Traditional Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 999 Years

Inclusion criteria

Inclusion criteria: (1) ICU admission within 48 hours meeting new definition of ARDS criteria ; (2) Age =18 years; (3) Signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Known allergy to TCM components in study drugs; (2) Expected death or palliative care within 24 hours; (3) Hypoxemia primarily caused by acute heart failure, pulmonary embolism, or asthma; (4) Pregnancy or lactation; (5) Participation in other clinical trials; (6) ALT/AST >8×ULN; (7) Severe renal impairment (CrCl 12); (9) Contraindications for enteral medication (e.g., mechanical ileus); (10) History of substance abuse or mental disorders.

Design outcomes

Primary

MeasureTime frame
28-Day All-Cause Mortality;

Secondary

MeasureTime frame
Ventilator-free days within 28 days;Oxygenation index changes;Changes in the Sequential Organ Failure Assessment score?;Organ failure-free days within 28 days;

Countries

China

Contacts

Public ContactGao Peiyang

Chengdu University of Traditional Chinese Medicine Affiliated Hospital

gaopy930@126.com18980025566

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026