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NCT06857487RecruitingPhase 1/2

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

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

Source: ClinicalTrials.gov · Last updated 1 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
72 (estimated)
First submitted
27 Feb 2025
Start date
13 Jun 2025
Primary completion date
24 Oct 2026
Lead sponsor
Dongzhimen Hospital, Beijing
Diseases
Stroke
NCT number
NCT06857487

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 72
  • From 13 Jun 2025 to the primary completion date, 24 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received or planned thrombolysis or endovascular therapy after onset.

Other illness

  • 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 aphasia or mental illness affecting clinical information collection and evaluation.

Lab values

  • 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)

Other

  • Pregnancy, potential pregnancy or breastfeeding.
  • Currently participating in other clinical trials.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Dongzhimen Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.