Acute Ischemic StrokePhase 1/2QUIETNCT06857487
Qingre Huatan Formula for the Prevention of Early Neurological Deterioration in Acute Ischemic Stroke
A Phase 1/2 study testing Qingre Huatan Formula in people with Acute Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Qingre Huatan Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2025to 29 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Xinxing Lai, 08615901111280, new-star@163.com
About this study
Official 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
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Qingre Huatan Formula, Qingre Huatan Formula placebo, Guidelines-based standard care
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qingre Huatan FormulaDrug
Qingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days.
Qingre Huatan Formula placeboDrug
Qingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days.
Guidelines-based standard careOther
Guidelines-based standard care for acute ischemic stroke
| Study group | Role | What they receive |
|---|---|---|
| Qingre Huatan Formula | Experimental | Patients will receive orally administered Qingre Huatan Formula, combined with guidelines-based standard care. Receives: Drug: Qingre Huatan Formula; Other: 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. Receives: Drug: Qingre Huatan Formula placebo; Other: Guidelines-based standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Basline and Day 7
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 90
Incidence of treatment-related adverse events
Number of patients with any adverse events during the study.
Measured: 90 days after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start13 Jun 2025
- Primary completion24 Oct 2026 (estimated)
- Study completion29 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857487
- Sponsor's protocol ID
- 2023DZMEC-410-02
- Acronym
- QUIET
- Status last verified
- Nov 2025
- First submitted
- 27 Feb 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng X, Yang Z, Wu H, Zhao M, Que C, Xiong X, Mu Y, Zhang G, Kang L, Gao Y, Lai X. Efficacy and safety of Qingre Huatan Formula for the prevention of early neurological deterioration in patients with acute ischemic stroke (QUIET): rationale and design for a randomized double-blind placebo-controlled study. Front Med (Lausanne). 2026 Apr 13;13:1754648. doi: 10.3389/fmed.2026.1754648. eCollection 2026.
PubMed 42051694
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06857487
- Acronym / sponsor ID
- QUIET / 2023DZMEC-410-02
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 24 Oct 2026 (estimated)
- Study completion
- 29 Oct 2026 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qingre Huatan Formula | Experimental | Drug: Qingre Huatan Formula, Other: Guidelines-based standard carePatients will receive orally administered Qingre Huatan Formula, combined with guidelines-based standard care. |
| Qingre Huatan Formula placebo | Placebo comparator | Drug: Qingre Huatan Formula placebo, Other: Guidelines-based standard carePatients will receive orally administered Qingre Huatan Formula placebo, combined with guidelines-based standard care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qingre Huatan FormulaQingre Huatan Formula, granules, 1 bag each time, twice a day, orally, continue for 10 days. | Drug | Qingre Huatan Formula |
| Qingre Huatan Formula placeboQingre Huatan Formula placebo, granules, 1 bag each time, twice a day, orally, continue for 10 days. | Drug | Qingre Huatan Formula placebo |
| Guidelines-based standard careGuidelines-based standard care for acute ischemic stroke | Other | Qingre Huatan Formula, Qingre Huatan Formula placebo |
Primary outcome
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.
6 secondary outcomes
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 proportion of patients with modified Rankin Scale score ≤2 on day 30
Time frame: Day 30
The proportion of patients with modified Rankin Scale score ≤2 on day 90
Time frame: Day 90
Activity of daily living of patients measured by Barthel Index score on day 30
Time frame: Day 30
Activity of daily living of patients measured by Barthel Index score on day 90
Time frame: Day 90
Incidence of treatment-related adverse events
Time frame: 90 days after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Derived from this study: PubMed 42051694Zheng X, Yang Z, Wu H, Zhao M, Que C, Xiong X, Mu Y, Zhang G, Kang L, Gao Y, Lai X. Efficacy and safety of Qingre Huatan Formula for the prevention of early neurological deterioration in patients with acute ischemic stroke (QUIET): rationale and design for a randomized double-blind placebo-controlled study. Front Med (Lausanne). 2026 Apr 13;13:1754648. doi: 10.3389/fmed.2026.1754648. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Qingre Huatan Formula in people with Acute Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of early neurological deterioration within 7 days of onset (time frame: Basline and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06857487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.