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Xuanbai Shengmai Decoction

Phase 3

Acute Respiratory Distress Syndrome (ARDS) | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment308
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07528196Study of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress SyndromePHASE3 NOT YET_RECRUITING 308Aug 20, 2026Dec 1, 2027Jun 5, 2026 -
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Study Endpoints
Primary Endpoints
28-day mortality
On day 28 of treatment

Mortality was calculated on day 28 of treatment.

Secondary Endpoints
Clinical scoring indicator: LIS
Before treatment,on day 3 of treatment,on day 7 of treatment
Inflammatory indicator: Interleukin-6 (IL-6,pg/mL)
Before treatment,on day 3 of treatment,on day 7 of treatment
Pulmonary vascular permeability indicator: Serum angiopoietin-2 (Ang-2,pg/mL)
Before treatment,on day 3 of treatment,on day 7 of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Control GroupNO_INTERVENTIONPatients in the control group will receive standard comprehensive Western medical treatment.
Treatment GroupEXPERIMENTALPatients 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.
Interventions
NameTypeDescription
Xuanbai Shengmai DecoctionDRUGPatients in the treatment group will receive Xuanbai Shengmai Decoction orally or via nasogastric gavage on the basis of standard comprehensive Western medical treatment. The decoction will be administered within 24 hours after enrollment, one dose per day in two divided administrations, for a total of 7 days.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo

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. Pa...

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