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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843765
• Other study ID #: 2007AA02Z4B2
• Status: Completed
• Phase: N/A
• First received: February 12, 2009
• Last updated: February 13, 2012
• Start date: December 2007
• Est. completion date: November 2010

Study information

• Verified date: February 2012
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1151
• Est. completion date: November 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• acupuncture, massage and basic TCM treatment
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.
• rehabilitation and WM basic treatment
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

Locations

Country	Name	City	State
China	China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Beijing Tiantan Hospital, Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIHSS Stroke Scale, relapse rate		360 days	No
Secondary	adverse event		360 days	Yes