Study of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome (NCT07528196) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Study of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome
308 participantsStarted 2026-08-20
Plain-language summary
Acute respiratory distress syndrome (ARDS) is a common clinical syndrome in the ICU characterized by extremely high mortality and complex pathogenesis.At present, research on individualized treatment, phenotypic differences, and therapeutic efficacy in ARDS has become a hotspot.As characterized by syndrome differentiation, traditional Chinese medicine (TCM) treatment emphasizes interindividual heterogeneity and personalized management, which is expected to serve as a breakthrough in multi-target immune regulation for ARDS. The primary objective of the study is to investigate the effect of Xuanbai Shengmai Decoction on the prognosis of patients with ARDS in a prospective randomized controlled trial. The secondary objective is to evaluate the safety of Xuanbai Shengmai Decoction in the treatment of patients with ARDS.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Met the diagnostic criteria for ARDS according to the 2023 updated global definition.
. Within 48 hours of meeting the diagnostic criteria.
. Aged ≥ 18 years and ≤ 85 years.
Exclusion criteria
. Did not meet the diagnostic criteria.
. Pregnant or lactating women.
. Patients with gastrointestinal dysfunction (including gastrointestinal bleeding, severe intra-abdominal hypertension, severe intestinal obstruction, etc.), resulting in the inability to administer medication via nasogastric/nasoenteric tube or orally within 48 hours after enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a traditional Chinese herbal formula called Xuanbai Shengmai Decoction for ARDS — can you explain what this treatment is and whether there's earlier-phase research showing it's safe and potentially effective before this Phase 3 study?
2The trial is measuring 28-day mortality as the main outcome, which means it's studying whether this treatment affects survival — given how serious ARDS is, does the existing evidence on this herbal decoction suggest it could realistically improve my chances compared to standard critical care?
3Since this trial isn't recruiting yet, how long might it be before it actually opens, and given how quickly ARDS develops and needs treatment, is waiting for this trial even a realistic option for my situation?
4Would enrolling in this trial mean I receive this herbal treatment alongside standard ARDS care, or could it replace any standard treatments, and how would that affect my overall management in the ICU?
5Are there other approved or well-established treatments for ARDS I should consider first, and would pursuing one of those now affect my eligibility if this trial does open and I later want to participate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.