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Completed

NCT Number: NCT00843765

Efficiency Study of Traditional Chinese Medicine (TCM) Versus Western Medicine (WM) on Ischemic Stroke

Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100700, China

About this study

As a multi-site randomized controlled clinical trial,through a central system,patients were randomly assigned to the intervention group or the control group.In the intervention group, patients were treated with the traditional Chinese medicine comprehensive rehabilitation program, which includes traditional Chinese medicine syndrome differentiation herbs, Chinese medicine injection, wash foam Chinese medicine, acupuncture,massage, and Chinese medicine health education. In the control group, patients were treated with Western-based treatment plus modern rehabilitation techniques.All patients were treated for 2 weeks. At the first day after the treatment and the 14 days after treatment, each patient was evaluated for the following three clinical indications: (1)evaluation of neurological deficits by U.S. National Institutes of Health Stroke Scale (NIHSS);(2) evaluation of motor function by the short form Fugl-Meyer motor function scoring system (FMI); and (3) assessment of limb spasticity by the modified Ashworth spasticity rating scale.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • According with the stroke diagnosis of Traditional Chinese Medicine
  • According to atherosclerotic thrombotic cerebral infarction from Western diagnosis such as medical history and CT / MRI examinations
  • It has attacked in 7 days
  • The assessment of scale of NIHSS:4-24 points
  • Age: ≥ 35 years and ≤ 75 years
  • Patients or their legal guardians sign informed consent form

Exclusion criteria

  • The patients with ICH or cerebral hemorrhage or TIA
  • It has attacked beyond 7 days
  • Patients with stroke history and the mRS ≥ 2 points before this attack
  • Mixed type of stroke (infarction after bleeding or bleeding after infarction)
  • Patients with cerebral infarction by cardiogenic embolism, blood hypercoagulable state and tunica intima exfoliating
  • Patients with serious heart disease;failure of heart or liver or kidney; cancer;digestive tract bleeding
  • Women of pregnancy or breast-feeding
  • Patients who are taking part in other clinical trials that will influence the results of this study

Treatment and study plan

acupuncture, massage and basic TCM treatment

Other
  • During hospitalization:Patients accept TCM rehabilitation and basic treatment including WM basic treatment and Chinese medicine injection,decoction,herb soak treatment and health education.
  • After discharge from hospital: In the TCM group,add prescriptions according to two conditions:a. patients using A injection (one Chinese herb injection admitted by SFDA) will take A' capsule (one Chinese herb capsule admitted by SFDA) for 6 months;b.patients using B injection (ditto) will take B' capsule (ditto) for 6 months.Both of them will accept TCM health education.In the WM group, patients are suggested with targeted rehabilitation programs according to different causes.

Other names: 863 TCM project for ischemic stroke-TCM group

rehabilitation and WM basic treatment

Other

there two steps:

  • during hospitalization: patients accept modern rehabilitation and basic treatment of life supporting and medicine using and health education
  • After discharge: make rehabilitation plans for patients including management of anticoagulant drugs, blood pressure, blood lipid and blood glucose, health education, and some suggestions for resisting alcohol ,smoking and reasonable diet

Other names: 863 TCM project for ischemic stroke-WM group

Primary outcomes

  1. NIHSS Stroke Scale, relapse rate

    Time frame: 360 days

Secondary outcomes

  1. adverse event

    Time frame: 360 days

Sponsors and collaborators

Lead sponsor

China Academy of Chinese Medical Sciences

Other

Collaborators

  • Beijing Tiantan Hospital
  • Dongzhimen Hospital, Beijing

Registry information

Official study title

Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Feb 13, 2009
Registry last updated
Feb 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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