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

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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

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.

Condition or disease Intervention/treatment Phase
Stroke Combination Product: Chinese medicine treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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.
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.

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.



Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Tongsheng Su, Professor, Shaanxi Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03077984    
Other Study ID Numbers: 201507001-05
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes