Acute StrokeNCT04813445
Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke
A study testing Xingnaojing injection in people with Acute Stroke and Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
The main purpose of this trial is to analyse the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke by Metabonomics, proteomics and clinical parameters. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Stroke, Ischemic Stroke
- What is being tested?
- Xingnaojing injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2021to 28 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Acute ischemic stroke；
- Symptom onset within 24 hours；
- 35 ≤ Age ≤ 80 years；
- 4 ≤ NIHSS ≤ 25；
- Patient or legally authorized representative has signed informed consent.
Who cannot join
- Expected length of hospital stay is less than 10 days;
- Planned or already receiving intravenous thrombolysis or endovascular treatment;
- Use of drugs with unknown composition within 1 week before enrollment;
- Patients with acute infectious diseases (e.g. acute pneumonia) or taking related drugs within 1 month before treatment in the group;
- Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
- Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
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- Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
- Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
- Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
- Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
- Other conditions that render outcomes or follow-up unlikely to be assessed;
- Known to be pregnant or breastfeeding;
- Currently receiving an investigational drug.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Ying Gao, MD, 0086-010-84013209, gaoying973@126.com
Ping Jiang, MD, 0086-18810923089, 18810923089@163.com
About this study
Official title: Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke(AXAIS): A Multicenter, Randomized, Open-label, Controlled Trial
The main purpose of this trial is to analyse the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke by Metabonomics, proteomics and clinical parameters.
Read the detailed description
Xingnaojing is widely used in China, but there is lack of sufficient and reasonable explanation of its intervention effects for acute ischemic stroke currently. The primary hypothesis of this trial is that , Compared with the blank control group, Xingnaojing will produce serial changes in plasma and urine metabolites and biomarkers at baseline (pre-dose), 8 days and 11days . The serial changes may be the potential support to explain the intervention effect of Xingnaojing. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 11 days.
- Conditions
- Acute Stroke, Ischemic Stroke
- Being tested
- Xingnaojing injection
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xingnaojing injectionDrug
Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Xingnaojing injection | Experimental | Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Interventions:
Drug: Xingnaojing injection Other: Standard care Receives: Drug: Xingnaojing injection |
| Standard care | No intervention | Subjects will receive guidelines-based standard care. Interventions: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of NIHSS score
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Measured: Baseline, 3 days, 7 days and 10 days
Secondary outcomes (9)
The proportion of NIHSS score from 0 to 1
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Measured: Baseline, 3 days, 7 days and 10 days
Patient reported outcome (PRO) scale of stroke
Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 0(worst score) to 180 (best score).
Measured: 10 days
The proportion of patients independent at 30 days and 90 days
The proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2. The mRS score ranges from 0 (best score) to 6 (worst score).
Measured: 30 days and 90 days
Cardio-cerebral vascular incident
Cardio-cerebral vascular incident were defined as stroke, acute coronary syndrome (acute ST-elevation myocardial infarction, acute non-ST-elevation myocardial infarction and unstable angina), vascular death, etc.
Measured: Within baseline and 90 days
The difference in proteomic and metabolomics
Through proteomics and metabonomics to explore whether there are different metabolites or proteins between the two groups.（It's not known whether there are differences in the human body between the two groups.We are in the exploratory stage.）
Measured: baseline (pre-dose), 7 days and 11days
State of consciousness
The state of consciousness evaluated by Glasgow Coma Scale at Baseline, 3 days, 7 days and 10 days. The Glasgow score ranges from 3(worst score) to 15 (best score).
Measured: Baseline, 3 days, 7 days and 10 days
Activities of daily living
Activities of daily living will be measured by Barthel Index score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Measured: 30 days and 90 days
Safety end points
Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
Measured: 10 days
Stroke related deaths and deaths from any cause
Stroke related deaths and deaths from any cause within 10 days and 90 days after symptom onset.
Measured: Within 10 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start28 May 2021
- Primary completion28 Jun 2022 (estimated)
- Study completion28 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Nantong University, Nanjing Brain Hospital, Affiliated Hospital of Chengde Medical University
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813445
- Sponsor's protocol ID
- 2018YFC1705001-05
- Status last verified
- Feb 2022
- First submitted
- 16 Mar 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke(AXAIS): A Multicenter, Randomized, Open-label, Controlled Trial
- ClinicalTrials.gov ID
- NCT04813445
- Acronym / sponsor ID
- 2018YFC1705001-05
- Conditions
- Acute Stroke, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Nantong University, Nanjing Brain Hospital, Affiliated Hospital of Chengde Medical University
- Study start
- 28 May 2021 (actual)
- Primary completion
- 28 Jun 2022 (estimated)
- Study completion
- 28 Sep 2022 (estimated)
- First posted
- 24 Mar 2021 (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 main purpose of this trial is to analyse the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke by Metabonomics, proteomics and clinical parameters.
Detailed description
Xingnaojing is widely used in China, but there is lack of sufficient and reasonable explanation of its intervention effects for acute ischemic stroke currently. The primary hypothesis of this trial is that , Compared with the blank control group, Xingnaojing will produce serial changes in plasma and urine metabolites and biomarkers at baseline (pre-dose), 8 days and 11days . The serial changes may be the potential support to explain the intervention effect of Xingnaojing. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 11 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xingnaojing injection | Experimental | Drug: Xingnaojing injectionSubjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Interventions: Drug: Xingnaojing injection Other: Standard care |
| Standard care | No intervention | –Subjects will receive guidelines-based standard care. Interventions: Other: Standard care |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Acute ischemic stroke；
- Symptom onset within 24 hours；
- 35 ≤ Age ≤ 80 years；
- 4 ≤ NIHSS ≤ 25；
- Patient or legally authorized representative has signed informed consent.
Key exclusion criteria (13 listed)
- Expected length of hospital stay is less than 10 days;
- Planned or already receiving intravenous thrombolysis or endovascular treatment;
- Use of drugs with unknown composition within 1 week before enrollment;
- Patients with acute infectious diseases (e.g. acute pneumonia) or taking related drugs within 1 month before treatment in the group;
- Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
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 |
|---|---|---|
| Xingnaojing injectionXingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days. | Drug | Xingnaojing injection |
Primary outcome
The change of NIHSS score
Time frame: Baseline, 3 days, 7 days and 10 days
The NIHSS score ranges from 0 (best score) to 42 (worst score).
9 secondary outcomes
The proportion of NIHSS score from 0 to 1
Time frame: Baseline, 3 days, 7 days and 10 days
Patient reported outcome (PRO) scale of stroke
Time frame: 10 days
The proportion of patients independent at 30 days and 90 days
Time frame: 30 days and 90 days
Cardio-cerebral vascular incident
Time frame: Within baseline and 90 days
The difference in proteomic and metabolomics
Time frame: baseline (pre-dose), 7 days and 11days
State of consciousness
Time frame: Baseline, 3 days, 7 days and 10 days
Activities of daily living
Time frame: 30 days and 90 days
Safety end points
Time frame: 10 days
Stroke related deaths and deaths from any cause
Time frame: Within 10 days and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xingnaojing injection in people with Acute Stroke and 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 18 Feb 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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 change of NIHSS score (time frame: Baseline, 3 days, 7 days and 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2022.