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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDongzhimen Hospital, Beijing

About this trial

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.

Eligibility criteria

Qualifiers

Inpatients diagnosed with acute ischemic stroke. Inpatients diagnosed of acute ischemic stroke.

Meet the criteria of TCM phlegm-heat syndrome

Patients at high-risk of END : Magnetic resonance imaging (MRI) reveals new ischemic lesions, with DWI-ASPECTS score ≤ 7, or presence of at least two risk factors of END.

Acute ischemic stroke within 48 hours after onset.

Disqualifiers

Received or planned thrombolysis or endovascular therapy after onset.

Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.

Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )

Diseases that cause motor dysfunction, including osteoarthritis, etc.

Trial design

Treatments tested in this trial

  • Qingre Huatan Formula
  • Qingre Huatan Formula placebo
  • Guidelines-based standard care

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators