Qingre Huatan formula to prevent early neurological worsening after acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 1/2 trial gives inpatients with acute ischemic stroke and Traditional Chinese Medicine (TCM) phlegm-heat syndrome either the Qingre Huatan formula or a matching placebo in addition to guidelines-based standard care. Eligible participants are 18–80 years old, within 48 hours of symptom onset, and at high risk of early neurological deterioration based on MRI (DWI-ASPECTS ≤ 7) or multiple clinical risk factors. The trial is conducted at Dongzhimen Hospital in Beijing and follows participants for early neurological outcomes and safety monitoring. Clinical neurological status and laboratory tests will be used to compare rates of early neurological deterioration and adverse events between groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Inpatients diagnosed with acute ischemic stroke. Inpatients diagnosed of acute ischemic stroke.
2. Meet the criteria of TCM phlegm-heat syndrome
3. 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.
4. Acute ischemic stroke within 48 hours after onset.
5. Aged 18-80 years, male or female.
6. The patient or representative has signed informed consent.

Exclusion Criteria:

1. Received or planned thrombolysis or endovascular therapy after onset.
2. Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.
3. Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )
4. Diseases that cause motor dysfunction, including osteoarthritis, etc.
5. Known severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminase \> 2 times the upper limit of normal value, serum creatinine \> 1.5 times the upper limit of normal value)
6. Known severe aphasia or mental illness affecting clinical information collection and evaluation.
7. Pregnancy, potential pregnancy or breastfeeding.
8. Currently participating in other clinical trials.

Where it's running

• Dongzhimen Hospital
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.