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

NCT ID: NCT06857487

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-13

Study Completion Date

2026-10-29

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Qingre Huatan Formula

Patients will receive orally administered Qingre Huatan Formula, combined with guidelines-based standard care.

Group Type EXPERIMENTAL

Qingre Huatan Formula

Intervention Type DRUG

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

Guidelines-based standard care

Intervention Type OTHER

Guidelines-based standard care for acute ischemic stroke

Qingre Huatan Formula placebo

Patients will receive orally administered Qingre Huatan Formula placebo, combined with guidelines-based standard care.

Group Type PLACEBO_COMPARATOR

Qingre Huatan Formula placebo

Intervention Type DRUG

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

Guidelines-based standard care

Intervention Type OTHER

Guidelines-based standard care for acute ischemic stroke

Interventions

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Qingre Huatan Formula

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

Intervention Type DRUG

Qingre Huatan Formula placebo

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

Intervention Type DRUG

Guidelines-based standard care

Guidelines-based standard care for acute ischemic stroke

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongzhimen Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Ying Gao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dongzhimen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xinxing Lai

Role: primary

08615901111280

Other Identifiers

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2023DZMEC-410-02

Identifier Type: -

Identifier Source: org_study_id

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