Qingre Huatan formula to prevent early neurological worsening after 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

This study will test whether adding the Qingre Huatan herbal formula to standard care can prevent early neurological worsening in adults who have had an acute ischemic stroke within 48 hours of symptom onset.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Dongzhimen Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06857487 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–80 with acute ischemic stroke within 48 hours, who meet TCM phlegm-heat syndrome criteria and are judged to be at high risk for early neurological deterioration, and who can give informed consent.

Not a fit: Patients who received or are planned for thrombolysis or endovascular therapy, have secondary causes of stroke, were already dependent before the stroke, have other diseases causing motor dysfunction, or have severe liver or kidney dysfunction are unlikely to benefit or are excluded from participation.

Why it matters

Potential benefit: If successful, the treatment could reduce early neurological worsening after acute ischemic stroke and help preserve function in the critical first days after stroke.

How similar studies have performed: Herbal and TCM approaches for acute stroke have produced mixed results and generally limited high-quality evidence, so this specific formula remains relatively untested in large randomized trials.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• Dongzhimen Hospital — Beijing, Beijing Municipality, China (Recruiting)

Conditions Acute Ischemic Stroke