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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: Guidelines-based standard care; Drug: Qingre Huatan Formula; Drug: Qingre Huatan Formula placebo

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100700
      • Recruiting
      • Dongzhimen Hospital
      • Contact: Xinxing Lai; Phone Number: 08615901111280; Email: new-star@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Qingre Huatan Formula; Patients will receive orally administered Qingre Huatan Formula, combined with guidelines-based standard care.	Other: Guidelines-based standard care; Guidelines-based standard care for acute ischemic stroke; Drug: Qingre Huatan Formula; Qingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days.
Placebo Comparator: Qingre Huatan Formula placebo; Patients will receive orally administered Qingre Huatan Formula placebo, combined with guidelines-based standard care.	Other: Guidelines-based standard care; Guidelines-based standard care for acute ischemic stroke; Drug: Qingre Huatan Formula placebo; Qingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in National Institute of Health Stroke Scale scores from baseline to 10 days (after the treatment)	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.	Basline and 10 days after treatment initiation
The proportion of patients with modified Rankin Scale score ≤2 on 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).	Day 30
The proportion of patients with modified Rankin Scale score ≤2 on 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).	Day 90
Activity of daily living of patients measured by Barthel Index score on 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).	Day 30
Activity of daily living of patients measured by Barthel Index score on 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).	Day 90
Incidence of treatment-related adverse events	Number of patients with any adverse events during the study.	90 days after treatment initiation

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2025
• Primary Completion (Estimated): October 24, 2026
• Study Completion (Estimated): October 29, 2026

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2023DZMEC-410-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No