Recruiting NCT06857487
Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Qingre Huatan Formula, Qingre Huatan Formula placebo, Guidelines-based standard care.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Interventions
- Drug Qingre Huatan Formula
Qingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days. - Drug Qingre Huatan Formula placebo
Qingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days. - Other Guidelines-based standard care
Guidelines-based standard care for acute ischemic stroke
Primary outcome measures
- The incidence of early neurological deterioration within 7 days of onset [Time frame: Basline and Day 7]
Secondary outcome measures (6)
- Change in National Institute of Health Stroke Scale scores from baseline to 10 days (after the treatment) [Time frame: Basline and 10 days after treatment initiation]
- The proportion of patients with modified Rankin Scale score ≤2 on day 30 [Time frame: Day 30]
- The proportion of patients with modified Rankin Scale score ≤2 on day 90 [Time frame: Day 90]
- Activity of daily living of patients measured by Barthel Index score on day 30 [Time frame: Day 30]
- Activity of daily living of patients measured by Barthel Index score on day 90 [Time frame: Day 90]
- Incidence of treatment-related adverse events [Time frame: 90 days after treatment initiation]
Eligibility criteria
Inclusion criteria
- Inpatients diagnosed with acute ischemic stroke. Inpatients diagnosed of acute ischemic stroke.
- Meet the criteria of TCM phlegm-heat syndrome
- 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.
- Acute ischemic stroke within 48 hours after onset.
- Aged 18-80 years, male or female.
- The patient or representative has signed informed consent.
Exclusion criteria
- Received or planned thrombolysis or endovascular therapy after onset.
- Suspected secondary stroke caused by brain tumor, brain trauma, hemopathy, etc.
- Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scare score ≥2 )
- Diseases that cause motor dysfunction, including osteoarthritis, etc.
- 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)
- Known severe aphasia or mental illness affecting clinical information collection and evaluation.
- Pregnancy, potential pregnancy or breastfeeding.
- Currently participating in other clinical trials.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Dongzhimen Hospital — Beijing
Publications
- Zheng X, Yang Z, Wu H, Zhao M, Que C, Xiong X, Mu Y, Zhang G, Kang L, Gao Y, Lai X. Efficacy and safety of Qingre Huatan Formula for the prevention of early neurological deterioration in patients with acute ischemic stroke (QUIET): rationale and design for a randomized double-blind placebo-controlled study. Front Med (Lausanne). 2026 Apr 13;13:1754648. doi: 10.3389/fmed.2026.1754648. eCollection 2 PMID 42051694
Identifiers
NCT: NCT06857487 · 2023DZMEC-410-02