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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00843765
Study type Interventional
Source China Academy of Chinese Medical Sciences
Contact
Status Completed
Phase N/A
Start date December 2007
Completion date November 2010

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