Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Acute Ischemic Stroke
NCT ID: NCT06857487
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2025-06-13
2026-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Qingre Huatan Formula
Patients will receive orally administered Qingre Huatan Formula, combined with guidelines-based standard care.
Qingre Huatan Formula
Qingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days.
Guidelines-based standard care
Guidelines-based standard care for acute ischemic stroke
Qingre Huatan Formula placebo
Patients will receive orally administered Qingre Huatan Formula placebo, combined with guidelines-based standard care.
Qingre Huatan Formula placebo
Qingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days.
Guidelines-based standard care
Guidelines-based standard care for acute ischemic stroke
Interventions
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Qingre Huatan Formula
Qingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days.
Qingre Huatan Formula placebo
Qingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days.
Guidelines-based standard care
Guidelines-based standard care for acute ischemic stroke
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Dongzhimen Hospital, Beijing
OTHER
Responsible Party
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Ying Gao
Professor
Locations
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Dongzhimen Hospital
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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2023DZMEC-410-02
Identifier Type: -
Identifier Source: org_study_id
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