NCT06857487

Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Acute Ischemic Stroke

Efficacy and Safety of Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Patients With Acute Ischemic Stroke : A Randomized Double-blind Placebo-controlled Pilot Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effectiveness and safety of Qingre Huatan formula versus placebo on preventing early neurological deterioration in patients with acute ischemic stroke within 48 hours after onset.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Qingre Huatan Formula	Qingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days.
DRUG	Qingre Huatan Formula placebo	Qingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days.
OTHER	Guidelines-based standard care	Guidelines-based standard care for acute ischemic stroke

Timeline

• Start date: 2025-06-13
• Primary completion: 2026-10-24
• Completion: 2026-10-29
• First posted: 2025-03-04
• Last updated: 2025-12-01

Locations

1 site across 1 country: China