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NCT Number: NCT06857487

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

Location status: Recruiting

Location contact

Xinxing Lai

CONTACT

[email protected]

08615901111280

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Qingre Huatan Formula

Drug

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

Qingre Huatan Formula placebo

Drug

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

Guidelines-based standard care

Other

Guidelines-based standard care for acute ischemic stroke

Primary outcomes

  1. The incidence of early neurological deterioration within 7 days of onset

    Time frame: Basline and Day 7

    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.

Secondary outcomes

  1. 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 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.

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

  5. Activity of daily living of patients measured by Barthel Index score on day 90

    Time frame: Day 90

    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).

  6. Incidence of treatment-related adverse events

    Time frame: 90 days after treatment initiation

    Number of patients with any adverse events during the study.

Sponsors and collaborators

Lead sponsor

Dongzhimen Hospital, Beijing

Other

Registry information

Official study 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

Acronym: QUIET

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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