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Study on the Clinical Efficacy of Chinese Medicine Treatment of Sequelae of Apoplexy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077984
Recruitment Status : Enrolling by invitation
First Posted : March 13, 2017
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Tongsheng Su, Shaanxi Hospital of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date March 14, 2017
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on the Clinical Efficacy of Chinese Medicine Treatment of Sequelae of Apoplexy
Official Title  ICMJE Not Provided
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Combination Product: Chinese medicine treatment
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 Arms  ICMJE
  • Experimental: the cohort of Chinese medicine treatment
    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.
    Intervention: Combination Product: Chinese medicine treatment
  • No Intervention: the cohort of western medicine treatment
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 7, 2017)
1660
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077984
Other Study ID Numbers  ICMJE 201507001-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Tongsheng Su, Shaanxi Hospital of Traditional Chinese Medicine
Study Sponsor  ICMJE Tongsheng Su
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shaanxi Hospital of Traditional Chinese Medicine
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP