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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Combination product: Chinese medicine treatment

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: Interventional
• Enrollment (Anticipated): 1660
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tongsheng Su

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (ACTUAL): March 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 201507001-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES