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

China Academy of Chinese Medical Sciences

Status

Completed

Conditions

Stroke

Treatments

Other: rehabilitation and WM basic treatment

Other: acupuncture, massage and basic TCM treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT00843765

2007AA02Z4B2

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,151 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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