Ischemic Stroke, AcutePhase 4PUBLISHNCT05559307
Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke
A Phase 4 study testing Xingnaojing injection in people with Ischemic Stroke, Acute, run by Ying Gao at 1 site in China.
Trial summary
The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Xingnaojing for mild-to-severe acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute
- 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2022to 31 Mar 2023
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Acute ischemic stroke；
- Symptom onset within 24 hours；
- 40 ≤ age ≤ 80 years;
- 4 ≤ NIHSS ≤ 25；
- Patient or legally authorized representative has signed informed consent.
Who cannot join
- Planned or already receiving intravenous thrombolysis or endovascular treatment;
- 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) ;
- 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);
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- 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;
- Use any drugs containing traditional Chinese medicine within 1 week before enrollment;
- Currently receiving an investigational drug.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital
Beijing
Qiu, 18182538201
About this study
Official title: Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke (PUBLISH): A Non-randomized, Open-label, Controlled Trial
The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Xingnaojing for mild-to-severe acute ischemic stroke.
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. In order to further clarify the main pharmacodynamic substances of Xingnaojing in the treatment of acute ischemic stroke, this study intends to carry out a non-randomized, open-label, controlled clinical trial. The primary hypothesis is that , compared with the control group, Xingnaojing will produce serial changes in plasma metabolites at baseline (pre-dose) and 7 days, as well as urine metabolites at baseline (pre-dose), 6 days, 7 days and 8 days. 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.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- Xingnaojing injection
- Medical subject headings
- 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 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Xingnaojing injection group | Experimental | Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Interventions:
Drugs:Xingnaojing injection Other: Standard care (eg. antiplatelet drugs and statins) Receives: Drug: Xingnaojing injection |
| Standard care group | No intervention | Subjects will receive guidelines-based standard care. Interventions: Other: Standard care (eg. antiplatelet drugs and statins) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at baseline.
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at baseline.
Measured: Baseline
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 6 days.
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 6 days.
Measured: 6 days
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 7 days.
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 7 days.
Measured: 7 days
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 8 days.
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 8 days.
Measured: 8 days
Secondary outcomes (6)
The change of neurological deficits
The change of neurological deficits is measured by the change of National Institute of Health Stroke Scale (NIHSS) score, ranging from 0 (best score) to 42 (worst score).
Measured: Baseline, 7 days
Patient reported outcome
Patient reported outcome is measured by Patient reported outcome (PRO) scale of stroke, ranging from 0(worst score) to 180 (best score).
Measured: 7 days
The proportion of life dependency
The proportion of life dependency is defined as Modified Rankin Scale (mRS) score 0-2. The mRS score ranges from 0 (best score) to 6 (worst score).
Measured: 30 days, 90 days
The degree of disability
The degree of disability is measured by the distribution proportion of mRS score, ranging from 0 (best score) to 6 (worst score).
Measured: 30 days, 90 days
Number of participants with cerebral vascular incidents
Cerebral vascular incidents are defined as stroke, transient ischemia attack, etc.
Measured: 90 days
Number of participants with cardio-cerebral vascular incidents
Cardio-cerebral vascular incidents are defined as stroke, acute coronary syndrome (acute ST-elevation myocardial infarction, acute non-ST-elevation myocardial infarction and unstable angina), etc.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start16 Aug 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Gao
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital
- Responsible party
- Sponsor-investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Gao, Principal investigator, Dongzhimen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559307
- Sponsor's protocol ID
- 2018YFC1705001-05-02
- Acronym
- PUBLISH
- Status last verified
- Sep 2022
- First submitted
- 11 Nov 2021
- Last updated
- 29 Sep 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 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke (PUBLISH): A Non-randomized, Open-label, Controlled Trial
- ClinicalTrials.gov ID
- NCT05559307
- Acronym / sponsor ID
- PUBLISH / 2018YFC1705001-05-02
- Conditions
- Ischemic Stroke, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ying GaoUniversity, hospital or other
- Collaborators
- Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 29 Sep 2022 (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 purposes of this trial are to analyze the pharmacodynamic substances and the effects of Xingnaojing for mild-to-severe acute ischemic stroke.
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. In order to further clarify the main pharmacodynamic substances of Xingnaojing in the treatment of acute ischemic stroke, this study intends to carry out a non-randomized, open-label, controlled clinical trial. The primary hypothesis is that , compared with the control group, Xingnaojing will produce serial changes in plasma metabolites at baseline (pre-dose) and 7 days, as well as urine metabolites at baseline (pre-dose), 6 days, 7 days and 8 days. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xingnaojing injection group | Experimental | Drug: Xingnaojing injectionSubjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Interventions: Drugs:Xingnaojing injection Other: Standard care (eg. antiplatelet drugs and statins) |
| Standard care group | No intervention | –Subjects will receive guidelines-based standard care. Interventions: Other: Standard care (eg. antiplatelet drugs and statins) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Acute ischemic stroke；
- Symptom onset within 24 hours；
- 40 ≤ age ≤ 80 years;
- 4 ≤ NIHSS ≤ 25；
- Patient or legally authorized representative has signed informed consent.
Key exclusion criteria (11 listed)
- Planned or already receiving intravenous thrombolysis or endovascular treatment;
- 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) ;
- 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);
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 7 days. | Drug | Xingnaojing injection group |
Primary outcome
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at baseline.
Time frame: Baseline
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at baseline.
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 6 days.
Time frame: 6 days
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 6 days.
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 7 days.
Time frame: 7 days
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 7 days.
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at 8 days.
Time frame: 8 days
Differences in the content of Borneol, Muscone, 1,8-Cineole in plasma and urine samples between Xingnaojing injection group and standard care group at 8 days.
6 secondary outcomes
The change of neurological deficits
Time frame: Baseline, 7 days
Patient reported outcome
Time frame: 7 days
The proportion of life dependency
Time frame: 30 days, 90 days
The degree of disability
Time frame: 30 days, 90 days
Number of participants with cerebral vascular incidents
Time frame: 90 days
Number of participants with cardio-cerebral vascular incidents
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 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.
Gao principal investigator
Dongzhimen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xingnaojing injection in people with Ischemic Stroke, Acute, run by Ying Gao 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 11 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 29 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Qin (17801222857, qinmz@bucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Borneol, Muscone, 1,8-Cineole between Xingnaojing injection group and standard care group at baseline. (time frame: Baseline). The study lists 4 primary outcomes in all. 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 29 Sep 2022.