NCT06857487

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
6mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jun 2025Oct 2026

First Submitted

Initial submission to the registry

February 27, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2026

Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

February 27, 2025

Last Update Submit

November 24, 2025

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • The incidence of early neurological deterioration within 7 days of onset

    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.

    Basline and Day 7

Secondary Outcomes (6)

  • Change in National Institute of Health Stroke Scale scores from baseline to 10 days (after the treatment)

    Basline and 10 days after treatment initiation

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

    Day 30

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

    Day 90

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

    Day 30

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

    Day 90

  • +1 more secondary outcomes

Study Arms (2)

Qingre Huatan Formula

EXPERIMENTAL

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

Drug: Qingre Huatan FormulaOther: Guidelines-based standard care

Qingre Huatan Formula placebo

PLACEBO COMPARATOR

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

Drug: Qingre Huatan Formula placeboOther: Guidelines-based standard care

Interventions

Qingre Huatan FormulaDRUG

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

Qingre Huatan Formula
Qingre Huatan Formula placeboDRUG

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

Qingre Huatan Formula placebo
Guidelines-based standard careOTHER

Guidelines-based standard care for acute ischemic stroke

Qingre Huatan FormulaQingre Huatan Formula placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 4, 2025

Study Start

June 13, 2025

Primary Completion (Estimated)

October 24, 2026

Study Completion (Estimated)

October 29, 2026

Last Updated

December 1, 2025

Record last verified: 2025-11

Locations

CN(1)