StrokeNCT03077984
Study on the Clinical Efficacy of Chinese Medicine Treatment of Sequelae of Apoplexy
A study testing Chinese medicine treatment in people with Stroke, run by Tongsheng Su.
Trial summary
This project is one multi-center, a prospective cohort study, based on 1660 cases of ischemic stroke patients with the treatment of 3 months, and 21 months of follow-up observation in order to clarify the advantages and characteristics of integrated treatment of traditional Chinese medicine sequela of apoplexy; With… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Chinese medicine treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,660 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in accordance with the criteria for the diagnosis of cerebral infarction.
- Functional Defects of Extremities1≤MRS≤5.
- Age between 18 and 75 years old (including 18 and 75), No gender limitation.
- Patients who agreed to participate in clinical trials and signed the informed consent form.
- Patients with stable vital signs after two weeks.
Who cannot join
- Patients with cerebral infarction at acute phase.
- Patients with cerebral infarction, transient ischemic attack, cerebral hemorrhage and cerebral arteritis.
- Patients with AF, ain tumor, brain trauma, brain parasite disease and rheumatic heart disease.
- Patients with bleeding or severe bleeding within 3 months.
- Patients with severe hepatitis, Kidneys, blood and the metabolic system diseases.
- Pisabilities and viewers with NIHSS prescribed by law.(Physical disabilities such as blind, deaf, dumb, mental disorder, mental disorder).
Show all 9Show fewer
- Patients with history of alcohol and drug abuse, will reduce the possibility or make it hard into the Project Group according to the researchers' judgment.
- Allergic constitutions and drug sensitivities.
- Patients in other clinical trials or clinical trials of other drugs for more than 3 months.
About this study
This project is one multi-center, a prospective cohort study, based on 1660 cases of ischemic stroke patients with the treatment of 3 months, and 21 months of follow-up observation in order to clarify the advantages and characteristics of integrated treatment of traditional Chinese medicine sequela of apoplexy; With the formation of curative effect, to highlight the advantage of the programme of comprehensive treatment of apoplectic sequela in traditional Chinese medicine and its compound preparation; To form a active medical service mode of stroke chronic disease management processes, as well as modalities and mechanisms for the evaluation of the curative effect.
Read the detailed description
There are more than 7 million stroke patients in China , about 2 million new cases of stroke patients each year, has become the national first cause of death, approximately 3/4 percent of survivors lost the ability to work due to apoplexy admitted to hospital 41.5% patients for recurrent patients. There is the legacy of somatic dysfunction in 80% of patients after stroke, The remaining 55.4% of the patients with mental disorders, The northwest region of China is a high incidence of "Stroke Belt" and the health care system in Northwest China is very weak, The "four high and one low" problem become more and more serious in the northwest, Therefore, clerify the advantages and characteristics of traditional Chinese medicine comprehensive treatment of sequelae of apoplexy. The formation of the active medical service model under the mode of stroke chronic disease management processes, and the evaluation of the curative effect and mechanism of paramount importance. In this paper 1660 cases of ischemic stroke patients with integrated traditional Chinese medicine therapy for 3 months, And 21-month follow-up observation To identify the traditional Chinese medicine comprehensive treatment to reduce mortality in patients with ischemic stroke recurrence rate, to improve the degree of disability of limbs after stroke and the effect of the main symptom of sequelae.
- Conditions
- Stroke
- Being tested
- Chinese medicine treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese medicine treatmentCombination product
The cohort of Chinese medicine treatment uses its comprehensive program of TCM on the basis of treatment with western medicine, including Chinese Herbs, acupuncture and acupoint application therapies.
| Study group | Role | What they receive |
|---|---|---|
| the cohort of Chinese medicine treatment | Experimental | The cohort of Chinese medicine treatment uses its comprehensive program of TCM on the basis of treatment with western medicine, including Chinese Herbs, acupuncture and acupoint application therapies. Receives: Combination Product: Chinese medicine treatment |
| the cohort of western medicine treatment | No intervention | The cohort of Western medicine treatment refers to the treatment of cerebrovascular disease prevention and cure guideline of China-related programmes, including anti-platelet aggregation, blood pressure,blood glucose,Blood Lipids lowering therapies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate of ischemic stroke
In this paper 1660 cases of ischemic stroke patients with integrated traditional Chinese medicine therapy for 3 months, And 21-month follow-up observation To identify the traditional Chinese medicine comprehensive treatment to reduce mortality in patients with ischemic stroke recurrence rate, to improve the degree of disability of limbs after stroke and the effect of the main symptom of sequelae.
Measured: to observe the recurrence rate of ischemic stroke 1 year later
improve the degree of disability of limbs after ischemic stroke
In this paper 1660 cases of ischemic stroke patients with integrated traditional Chinese medicine therapy for 3 months, And 21-month follow-up observation To identify the traditional Chinese medicine comprehensive treatment to improve the degree of disability of limbs after stroke and the effect of the main symptom of sequelae.
Measured: to observe the degree of disability of limbs after ischemic stroke 2 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongsheng Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tongsheng Su, Shaanxi Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077984
- Sponsor's protocol ID
- 201507001-05
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2017
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Clinical Efficacy of Chinese Medicine Treatment of Sequelae of Apoplexy
- ClinicalTrials.gov ID
- NCT03077984
- Acronym / sponsor ID
- 201507001-05
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,660 participants (estimated)
- Lead sponsor
- Tongsheng SuUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Mar 2017 (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 project is one multi-center, a prospective cohort study, based on 1660 cases of ischemic stroke patients with the treatment of 3 months, and 21 months of follow-up observation in order to clarify the advantages and characteristics of integrated treatment of traditional Chinese medicine sequela of apoplexy; With the formation of curative effect, to highlight the advantage of the programme of comprehensive treatment of apoplectic sequela in traditional Chinese medicine and its compound preparation; To form a active medical service mode of stroke chronic disease management processes, as well as modalities and mechanisms for the evaluation of the curative effect.
Detailed description
There are more than 7 million stroke patients in China , about 2 million new cases of stroke patients each year, has become the national first cause of death, approximately 3/4 percent of survivors lost the ability to work due to apoplexy admitted to hospital 41.5% patients for recurrent patients. There is the legacy of somatic dysfunction in 80% of patients after stroke, The remaining 55.4% of the patients with mental disorders, The northwest region of China is a high incidence of "Stroke Belt" and the health care system in Northwest China is very weak, The "four high and one low" problem become more and more serious in the northwest, Therefore, clerify the advantages and characteristics of traditional Chinese medicine comprehensive treatment of sequelae of apoplexy. The formation of the active medical service model under the mode of stroke chronic disease management processes, and the evaluation of the curative effect and mechanism of paramount importance. In this paper 1660 cases of ischemic stroke patients with integrated traditional Chinese medicine therapy for 3 months, And 21-month follow-up observation To identify the traditional Chinese medicine comprehensive treatment to reduce mortality in patients with ischemic stroke recurrence rate, to improve the degree of disability of limbs after stroke and the effect of the main symptom of sequelae.
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 |
|---|---|---|
| the cohort of Chinese medicine treatment | Experimental | Combination Product: Chinese medicine treatmentThe cohort of Chinese medicine treatment uses its comprehensive program of TCM on the basis of treatment with western medicine, including Chinese Herbs, acupuncture and acupoint application therapies. |
| the cohort of western medicine treatment | No intervention | –The cohort of Western medicine treatment refers to the treatment of cerebrovascular disease prevention and cure guideline of China-related programmes, including anti-platelet aggregation, blood pressure,blood glucose,Blood Lipids lowering therapies. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients in accordance with the criteria for the diagnosis of cerebral infarction.
- Functional Defects of Extremities1≤MRS≤5.
- Age between 18 and 75 years old (including 18 and 75), No gender limitation.
- Patients who agreed to participate in clinical trials and signed the informed consent form.
- Patients with stable vital signs after two weeks.
Key exclusion criteria (9 listed)
- Patients with cerebral infarction at acute phase.
- Patients with cerebral infarction, transient ischemic attack, cerebral hemorrhage and cerebral arteritis.
- Patients with AF, ain tumor, brain trauma, brain parasite disease and rheumatic heart disease.
- Patients with bleeding or severe bleeding within 3 months.
- Patients with severe hepatitis, Kidneys, blood and the metabolic system 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 |
|---|---|---|
| Chinese medicine treatmentThe cohort of Chinese medicine treatment uses its comprehensive program of TCM on the basis of treatment with western medicine, including Chinese Herbs, acupuncture and acupoint application therapies. | Combination product | the cohort of Chinese medicine treatment |
Primary outcome
recurrence rate of ischemic stroke
Time frame: to observe the recurrence rate of ischemic stroke 1 year later
In this paper 1660 cases of ischemic stroke patients with integrated traditional Chinese medicine therapy for 3 months, And 21-month follow-up observation To identify the traditional Chinese medicine comprehensive treatment to reduce mortality in patients with ischemic stroke recurrence rate, to improve the degree of disability of limbs after stroke and the effect of the main symptom of sequelae.
improve the degree of disability of limbs after ischemic stroke
Time frame: to observe the degree of disability of limbs after ischemic stroke 2 year later
In this paper 1660 cases of ischemic stroke patients with integrated traditional Chinese medicine therapy for 3 months, And 21-month follow-up observation To identify the traditional Chinese medicine comprehensive treatment to improve the degree of disability of limbs after stroke and the effect of the main symptom of sequelae.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: Yes
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
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 Chinese medicine treatment in people with Stroke, run by Tongsheng Su.
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 9 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 14 Mar 2017. 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?
Results are not available in the source record.
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?
recurrence rate of ischemic stroke (time frame: to observe the recurrence rate of ischemic stroke 1 year later). The study lists 2 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 14 Mar 2017.