Study of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome

Southeast University, China

Status and phase: Not yet enrolling; Phase 3

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Treatments: Drug: Xuanbai Shengmai Decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT07528196

2025ZDSYLL563-P01 (Other Identifier)

Xuanbai Shengmai Decoction

Details and patient eligibility

About

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.

Enrollment: 308 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Met the diagnostic criteria for ARDS according to the 2023 updated global definition.
2. Within 48 hours of meeting the diagnostic criteria.
3. Aged ≥ 18 years and ≤ 85 years.

Exclusion criteria

1. Did not meet the diagnostic criteria.
2. Pregnant or lactating women.
3. 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.
4. SOFA score > 13.
5. Hypersensitivity to the study drugs.
6. Withdrawal of treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

308 participants in 2 patient groups

Control Group

No Intervention group

Description:

Patients in the control group will receive standard comprehensive Western medical treatment.

Treatment Group

Experimental group

Description:

Patients in the treatment group will receive Xuanbai Shengmai Decoction via oral administration or nasogastric feeding on the basis of standard comprehensive Western medical treatment. The decoction will be administered within 24 hours after enrollment, one dose per day divided into two administrations, for a total treatment duration of 7 days.

Treatment:

Drug: Xuanbai Shengmai Decoction