Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Acute Ischemic St… (NCT06857487) | Clinical Trial Compass
RecruitingPhase 1/2
Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Acute Ischemic Stroke
China72 participantsStarted 2025-06-13
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of early neurological deterioration within 7 days of onset
. 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.