Clinical trial NCT06857487: Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Acute Ischemic Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: The incidence of early neurological deterioration within 7 days of onset
timeFrame: Basline and Day 7
Secondary outcomes:
measure: Change in National Institute of Health Stroke Scale scores from baseline to 10 days (after the treatment)
timeFrame: Basline and 10 days after treatment initiation
measure: The proportion of patients with modified Rankin Scale score ≤2 on day 30
timeFrame: Day 30
measure: The proportion of patients with modified Rankin Scale score ≤2 on day 90
timeFrame: Day 90
measure: Activity of daily living of patients measured by Barthel Index score on day 30
timeFrame: Day 30
measure: Activity of daily living of patients measured by Barthel Index score on day 90
timeFrame: Day 90
measure: Change in Traditional Chinese Medicine syndromes of patients measured by Stroke Syndrome Factor Evaluation Scale from baseline to 10 days (after the treatment)
timeFrame: Basline and 10 days after treatment initiation
measure: Incidence of treatment-related adverse events
timeFrame: 90 days after treatment initiation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
Study officials:
References: