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Shengdi Dahuang Decoction in Acute Hemorrhagic Stroke
NCT04200781Phase 4
Key facts
- Status
- Unknown
- Start
- Sep 2019
- Primary completion
- Jun 2022
- Countries
- 1
- Sponsor
- Shuguang Hospital
- Modality
- Herbal Formulation
- Conditions
- hemorrhagic stroke
01
Overview
Phase 4, randomised, double-blind trial in hemorrhagic stroke comparing Shengdi Dahuang Decoction with Placebo (2 arms). Primary endpoints: Disability rate (Modified Rankin Scale) at 90 days and Mortality rate at 7 days. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Shengdi Dahuang Decoction
Granules containing 15g rehmannia and 5g rhubarb, twice daily for 7 days
Placebo
Placebo granules containing 2% rehmannia and rhubarb, twice daily for 7 days
03
Who it enrols
Adult patients with acute intracerebral hemorrhage (<80ml) within 12 hours of onset, excluding those with severe coma (GCS <= 5), planned surgery, or secondary hemorrhage causes.
04
Endpoints
Primary
Disability rate (Modified Rankin Scale)
Mortality rate
Secondary
Mortality rate
National Institute of Health Stroke Scale
Proportion of hematoma enlargement cases
Severity of edema
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