Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
NCT06857487

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

Led by Dongzhimen Hospital, Beijing · Updated on 2025-12-01

72

Participants Needed

1

Research Sites

71 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Inpatients diagnosed with acute ischemic stroke
  • Meet the criteria of traditional Chinese medicine phlegm-heat syndrome
  • At high risk of early neurological deterioration (MRI shows new ischemic lesions with DWI-ASPECTS score 64 7, or presence of at least two risk factors of early neurological deterioration)
  • Stroke onset within 48 hours prior to enrollment
  • Aged 18 to 80 years, male or female
  • Patient or representative has signed informed consent
Not Eligible

You will not qualify if you...

  • Received or planned thrombolysis or endovascular therapy after stroke onset
  • Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, or similar conditions
  • Dependent in daily activities before the current stroke (modified Rankin Scale score 652)
  • Diseases causing motor dysfunction such as osteoarthritis
  • Known severe liver or kidney dysfunction (elevated liver enzymes or creatinine beyond specified limits)
  • Severe aphasia or mental illness affecting information collection and evaluation
  • Pregnancy, potential pregnancy, or breastfeeding
  • Currently participating in other clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dongzhimen Hospital

Beijing, Beijing Municipality, China, 100700

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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