Study on the Clinical Efficacy of Chinese Medicine Treatment of Sequelae of Apoplexy
1 other identifier
interventional
1,660
0 countries
N/A
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jan 2017
Longer than P75 for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 24, 2017
CompletedFirst Posted
Study publicly available on registry
March 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 14, 2017
January 1, 2017
1.9 years
January 24, 2017
March 13, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
to observe the degree of disability of limbs after ischemic stroke 2 year later
Study Arms (2)
the cohort of Chinese medicine treatment
EXPERIMENTALThe 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 INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongsheng Sulead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 24, 2017
First Posted
March 13, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2020
Last Updated
March 14, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share