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

Phase 2RecruitingNCT06857487

Dongzhimen Hospital, Beijing72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Ischemic Stroke

Interventions

Qingre Huatan FormulaDRUG

Qingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days.

Qingre Huatan Formula placeboDRUG

Qingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days.

Guidelines-based standard careOTHER

Guidelines-based standard care for acute ischemic stroke

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

The incidence of early neurological deterioration within 7 days of onset

An increase of NIHSS ≥2 within 7 days of onset is considered as early neurological deterioration. The NIHSS (National Institute of Health Stroke Scale) is a neurological assessment tool for stroke patients, with scores ranging from 0 to 42.

Time frame: Basline and Day 7

Secondary Outcomes

Change in National Institute of Health Stroke Scale scores from baseline to 10 days (after the treatment)

The NIHSS (National Institute of Health Stroke Scale) is a neurological assessment tool for stroke patients, with scores ranging from 0 to 42. Scores of 0-1 indicate near normal status, 1-4 mild stroke, 5-15 moderate stroke, 16-20 moderate-to-severe stroke, and 21-42 severe stroke. It is primarily used to quickly assess stroke severity and guide treatment decisions.

Time frame: Basline and 10 days after treatment initiation

The proportion of patients with modified Rankin Scale score ≤2 on day 30

The mRS (modified Rankin Scale) is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).

Time frame: Day 30

The proportion of patients with modified Rankin Scale score ≤2 on day 90

The mRS (modified Rankin Scale) is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).

Time frame: Day 90

Activity of daily living of patients measured by Barthel Index score on day 30

Barthel Index is a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best).

Time frame: Day 30

Data from ClinicalTrials.gov

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