Cerebral InfarctionNCT06549582
Th Tl Xb Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients
A study testing Taohong Tongluo Xiaoban Prescription and Fundamental medical treatment in people with Cerebral Infarction and Chinese Herbal Medicine, run by Yan Zhu.
Trial summary
This study is a prospective, open-label, randomized control trial. It is planning to include 160 cerebral infarction patients which will be randomized in a 1﹕1 fashion to receive Chinese herbal medicines combined basic medicine treatment, or to receive standard basic medicine treatment within 3 months after inclusion. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cerebral Infarction, Chinese Herbal Medicine, Clinical Trial
- What is being tested?
- Taohong Tongluo Xiaoban Prescription and Fundamental medical treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2026
- Phase
- Interventional
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The CT/MRI examination findings were consistent with the diagnosis of Western cerebral infarction, aligning with the TCM apoplexy diagnosis. Primary stroke occurred 35±5 days ago.
- The National Institutes of Health Stroke Scale (NIHSS) evaluates a range of scores from 4 to 24.
- Coronary atherosclerotic heart disease is confirmed through coronary CT angiography. Carotid artery ultrasonography is employed to ascertain the presence or absence of plaque formation, with stable plaques exhibiting predominantly high and uneven echogenicity, while unstable plaques displayed low echo or irregular hypoechoic regions.
- Age range: ≥35 years to ≤80 years.
- First onset requires; patients with previous diseases and no sequelae such as limb paralysis should not affect the NIHSS score, and the modified Rankin scale (mRS) score should be ≤1 point.
- Patient informed consent must be obtained.
- The criteria for the syndrome of phlegm and blood stasis are as follows: Main syndrome: hemiplegia, mouth and eyes skew, speech retarding or silent, sensation diminished or disappeared; Secondary syndrome: excessive sputum, fat tongue with teeth marks on the side, dark red tongue, sublingual vein blue or tortuous, tongue spots, white or thick greasy fur, pulse slippery.
- -
Who cannot join
- subarachnoid hemorrhage, transient ischemic attack, or other intracranial lesions such as intracranial tumor, aneurysm, vascular malformation, cerebral cysticercosis, intracerebral schistosomiasis, encephalitis, meningitis, hydrocephalus, and sequelae of brain trauma; Nonatherosclerotic thrombotic cerebral infarction (e.g., cardiogenic embolism, hypercoagulability disorders, endovascular shedding and arteritis);
- onset occurring within a range of 30 to 40 days；
- The patient presents with limb motor dysfunction, emotional disorder, cognitive impairment, or speech impairment resulting from pre-existing conditions (e.g., surgery, trauma, or congenital disability) prior to the onset of cerebrovascular accident.
- Patients with severe cardiac disease, heart failure, liver or kidney failure, malignant tumors, gastrointestinal bleeding, severe infections, or uncontrolled diabetes are excluded from the study.
- Individuals currently participating in other clinical trials are not eligible for inclusion.
- Exclusion criteria include patients with mental illness, multiple body ulcers or joint contractures.
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- Non-compliance with treatment by patients and their families is considered an exclusion criterion.
- Inability to comprehend the content of informed consent and inability to provide a signature on the informed consent form are also grounds for exclusion.
- . Pregnant and lactating women are excluded from participation.
- -
About this study
Official title: Effect of Taohong Tongluo Xiaoban Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients：a Randomized Controlled Clinical Trial
This study is a prospective, open-label, randomized control trial. It is planning to include 160 cerebral infarction patients which will be randomized in a 1﹕1 fashion to receive Chinese herbal medicines combined basic medicine treatment, or to receive standard basic medicine treatment within 3 months after inclusion. Follow-up will be performed after the treatment for 3 months to evaluate the incidence and disability rates of limb impairment, language impairment, cognitive impairment, and emotional disorders. The primary outcome is modified Rankin Scale Score, which is measured by the overall distribution from 0 (no symptoms) to 6 (death). The secondary outcome include the Evaluation of Neurological Function Deficit score (National Institute of Health stroke scale scoring) and carotid atherosclerotic plaque score (Crouse scoring system for neck carotid atherosclerotic plaque scoring). Additional outcomes include laboratory indicator to analysis the reprogramming of lipid metabolism and endothelial Injury, Chinese medicine symptom and sign scoring system and biological indicators. The investigators will perform the intention-to-treat analysis for withdrawal and missing data, and estimate the health economic value.
- Conditions
- Cerebral Infarction, Chinese Herbal Medicine, Clinical Trial, Lipid Metabolism Disorder, Endothelial Injury
- Being tested
- Taohong Tongluo Xiaoban Prescription, Fundamental medical treatment
- Medical subject headings
- Cerebral Infarction, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taohong Tongluo Xiaoban PrescriptionOther
Chinese herbal medicine "Taohong Tongluo Xiaoban prescription", which includes Pinelliae Rhizoma, Poria, Bambusae caulis in taenias, Aurantii Fructus Immaturus, Arisaema cum bile, Acori Tatarinowii Rhizoma, Persicae Semen, Carthami Flos, Chuanxiong Rhizoma and Paeoniae Radix Rubra as a once - daily dosage with one administration per dose
Fundamental medical treatmentOther
The specific methods were developed in accordance with the 2010 Chinese Guidelines for Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack. It primarily involves managing risk factors such as hypertension, diabetes, abnormal lipid metabolism, etc., and implementing antithrombotic therapy including antiplatelet agents (aspirin, clopidogrel, dipyridamole, dipyridamole + aspirin, clopidogrel + aspirin, silostazole, triflurosal, etc). For the management of post-stroke mood disorders, cognitive impairments, and spastic paralysis, pharmacological interventions encompass oral administration of anxiolytic or antidepressant agents, anti-dementia medications, as well as muscle relaxants.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Fundamental medical treatment+Taohong Tongluo Xiaoban Prescription Incorporating the Taohong Tongluo Xiaoban prescription, which includes Pinelliae Rhizoma, Poria, Bambusae caulis in taenias, Aurantii Fructus Immaturus, Arisaema cum bile, Acori Tatarinowii Rhizoma, Persicae Semen, Carthami Flos, Chuanxiong Rhizoma and Paeoniae Radix Rubra as a once - daily dosage with one administration per dose. Receives: Other: Taohong Tongluo Xiaoban Prescription; Other: Fundamental medical treatment |
| control group | Active comparator | Fundamental medical treatment The specific methods were developed in accordance with the 2010 Chinese Guidelines for Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack. It primarily involves managing risk factors such as hypertension, diabetes, abnormal lipid metabolism, etc., and implementing antithrombotic therapy including antiplatelet agents (aspirin, clopidogrel, dipyridamole, dipyridamole + aspirin, clopidogrel + aspirin, silostazole, triflurosal, etc). For the management of post-stroke mood disorders, cognitive impairments, and spastic paralysis, pharmacological interventions encompass oral administration of anxiolytic or antidepressant agents, anti-dementia medications, as well as muscle relaxants. Receives: Other: Fundamental medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale Score
Higher scores mean a worse outcome,measured by the overall distribution from 0 (no symptoms) to 6 (death).
Measured: 0,30days,60days and 90days post-intervention
Secondary outcomes (2)
National Institutes of Health Stroke Scale (NIHSS)
Higher scores mean a worse outcome,measured by the overall distribution from 0 (normal) to 42 (severe apoplexy).
Measured: 0,30days,60days and 90days post-intervention
Carotid atherosclerotic plaque score
Course scoring system for neck carotid atherosclerotic plaque scoring. Higher scores mean a worse outcome,the minimum value is 0 . The plaque score of the carotid artery on each side was calculated by summing up the maximum thickness (mm) of isolated carotid artery plaques, and the total plaque score of each patient was obtained by adding up the plaque scores from both sides.
Measured: 0 and 90days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Zhu, Beijing Electric Power Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549582
- Sponsor's protocol ID
- Th Tl Xb PrescriptionlY2024007
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Taohong Tongluo Xiaoban Prescription on Reprogramming of Lipid Metabolism and Endothelial Injury for Cerebral Infarction Patients：a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06549582
- Acronym / sponsor ID
- Th Tl Xb PrescriptionlY2024007
- Conditions
- Cerebral Infarction, Chinese Herbal Medicine, Clinical Trial, Lipid Metabolism Disorder, Endothelial Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yan ZhuUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Aug 2024 (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.
This study is a prospective, open-label, randomized control trial. It is planning to include 160 cerebral infarction patients which will be randomized in a 1﹕1 fashion to receive Chinese herbal medicines combined basic medicine treatment, or to receive standard basic medicine treatment within 3 months after inclusion. Follow-up will be performed after the treatment for 3 months to evaluate the incidence and disability rates of limb impairment, language impairment, cognitive impairment, and emotional disorders. The primary outcome is modified Rankin Scale Score, which is measured by the overall distribution from 0 (no symptoms) to 6 (death). The secondary outcome include the Evaluation of Neurological Function Deficit score (National Institute of Health stroke scale scoring) and carotid atherosclerotic plaque score (Crouse scoring system for neck carotid atherosclerotic plaque scoring). Additional outcomes include laboratory indicator to analysis the reprogramming of lipid metabolism and endothelial Injury, Chinese medicine symptom and sign scoring system and biological indicators. The investigators will perform the intention-to-treat analysis for withdrawal and missing data, and estimate the health economic value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Taohong Tongluo Xiaoban Prescription, Other: Fundamental medical treatmentFundamental medical treatment+Taohong Tongluo Xiaoban Prescription Incorporating the Taohong Tongluo Xiaoban prescription, which includes Pinelliae Rhizoma, Poria, Bambusae caulis in taenias, Aurantii Fructus Immaturus, Arisaema cum bile, Acori Tatarinowii Rhizoma, Persicae Semen, Carthami Flos, Chuanxiong Rhizoma and Paeoniae Radix Rubra as a once - daily dosage with one administration per dose. |
| control group | Active comparator | Other: Fundamental medical treatmentFundamental medical treatment The specific methods were developed in accordance with the 2010 Chinese Guidelines for Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack. It primarily involves managing risk factors such as hypertension, diabetes, abnormal lipid metabolism, etc., and implementing antithrombotic therapy including antiplatelet agents (aspirin, clopidogrel, dipyridamole, dipyridamole + aspirin, clopidogrel + aspirin, silostazole, triflurosal, etc). For the management of post-stroke mood disorders, cognitive impairments, and spastic paralysis, pharmacological interventions encompass oral administration of anxiolytic or antidepressant agents, anti-dementia medications, as well as muscle relaxants. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The CT/MRI examination findings were consistent with the diagnosis of Western cerebral infarction, aligning with the TCM apoplexy diagnosis. Primary stroke occurred 35±5 days ago.
- The National Institutes of Health Stroke Scale (NIHSS) evaluates a range of scores from 4 to 24.
- Coronary atherosclerotic heart disease is confirmed through coronary CT angiography. Carotid artery ultrasonography is employed to ascertain the presence or absence of plaque formation, with stable plaques exhibiting predominantly high and uneven echogenicity, while unstable plaques displayed low echo or irregular hypoechoic regions.
- Age range: ≥35 years to ≤80 years.
- First onset requires; patients with previous diseases and no sequelae such as limb paralysis should not affect the NIHSS score, and the modified Rankin scale (mRS) score should be ≤1 point.
Key exclusion criteria (10 listed)
- subarachnoid hemorrhage, transient ischemic attack, or other intracranial lesions such as intracranial tumor, aneurysm, vascular malformation, cerebral cysticercosis, intracerebral schistosomiasis, encephalitis, meningitis, hydrocephalus, and sequelae of brain trauma; Nonatherosclerotic thrombotic cerebral infarction (e.g., cardiogenic embolism, hypercoagulability disorders, endovascular shedding and arteritis);
- onset occurring within a range of 30 to 40 days；
- The patient presents with limb motor dysfunction, emotional disorder, cognitive impairment, or speech impairment resulting from pre-existing conditions (e.g., surgery, trauma, or congenital disability) prior to the onset of cerebrovascular accident.
- Patients with severe cardiac disease, heart failure, liver or kidney failure, malignant tumors, gastrointestinal bleeding, severe infections, or uncontrolled diabetes are excluded from the study.
- Individuals currently participating in other clinical trials are not eligible for inclusion.
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 |
|---|---|---|
| Taohong Tongluo Xiaoban PrescriptionChinese herbal medicine "Taohong Tongluo Xiaoban prescription", which includes Pinelliae Rhizoma, Poria, Bambusae caulis in taenias, Aurantii Fructus Immaturus, Arisaema cum bile, Acori Tatarinowii Rhizoma, Persicae Semen, Carthami Flos, Chuanxiong Rhizoma and Paeoniae Radix Rubra as a once - daily dosage with one administration per dose | Other | intervention group |
| Fundamental medical treatmentThe specific methods were developed in accordance with the 2010 Chinese Guidelines for Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack. It primarily involves managing risk factors such as hypertension, diabetes, abnormal lipid metabolism, etc., and implementing antithrombotic therapy including antiplatelet agents (aspirin, clopidogrel, dipyridamole, dipyridamole + aspirin, clopidogrel + aspirin, silostazole, triflurosal, etc). For the management of post-stroke mood disorders, cognitive impairments, and spastic paralysis, pharmacological interventions encompass oral administration of anxiolytic or antidepressant agents, anti-dementia medications, as well as muscle relaxants. | Other | control group, intervention group |
Primary outcome
Modified Rankin Scale Score
Time frame: 0,30days,60days and 90days post-intervention
Higher scores mean a worse outcome,measured by the overall distribution from 0 (no symptoms) to 6 (death).
2 secondary outcomes
National Institutes of Health Stroke Scale (NIHSS)
Time frame: 0,30days,60days and 90days post-intervention
Carotid atherosclerotic plaque score
Time frame: 0 and 90days post-intervention
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 14 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Taohong Tongluo Xiaoban Prescription and Fundamental medical treatment in people with Cerebral Infarction and Chinese Herbal Medicine, run by Yan Zhu.
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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale Score (time frame: 0,30days,60days and 90days post-intervention). 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 14 Aug 2024.