Condition category
Circulatory System
Date applied
11/04/2010
Date assigned
29/04/2010
Last edited
29/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lingpeng Wang

ORCID ID

Contact details

Beijing Hospital of Traditional Chinese Medicine
No.23 Meishuguanhoujie
Dongcheng Dis.
Beijing
100010
China
+86 (0)10 5217 6636
wlp5558@sina.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D08050703550902

Study information

Scientific title

The effect of acupuncture versus standard Western therapy in reducing the rate of deformity of stroke and in improving the quality of life in adult patients: a multicentre randomised controlled trial

Acronym

EASR

Study hypothesis

Under the guidance of the theory of Chinese medicine, acupuncture is widely used in treating the stroke in China for a long time. This study is to evaluate the effect of acupuncture in reducing the rate of deformity of stroke and in improving the quality of life.

Ethics approval

Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine approved on the 22nd January 2010 (ref: 201002-1)

Study design

Multicentre randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact shizheng83@hotmail.com to request a patient information sheet

Condition

Stroke

Intervention

A total of 328 patients on the acute stage of cerebral apoplexy will be recruited. The patients were randomly divided into two different groups: the intervention group received the treatment of acupuncture and the Western Medicine standard treatment for 3 months and the secondary prevention treatment for 6 months, and the control group received the standard therapy of the Western medicine for 3 months and the secondary prevention treatment for 6 months. Both groups were evaluated with the treatment course of 4 weeks, 12 weeks and 24 weeks.

Group A (intervention group):
Patients are stimulated by 7 main acupoints: Baihui (Du-20), Quchi (LI-11), Shousanli (LI-10), Hegu (LI-4), Zusanli (ST-36), Yanglingquan (GB-34), Sanyinjiao (SP-6). Acupoints association is used under the guidance of the theory of Chinese medicine and according to the patients' different symptoms, the acupoints below are commonly used: Jianyu (LI-15), Huantiao (GB-10), Qiuxu (GB40), twelve well-jing points, Jinjin (EX-HN 12), Yuye (EX-HN 13), Yamen (DU-15), Lianquan (RN 23), Tianshu (ST-25), Fenglong (ST-40), limb spasm assists with fire needles.

The acupoints are stimulated by the filiform needles and the needles are remained for 30 minutes. Patients on the acute stage are treated with the acupoints of Baihui (Du-20), Jinjin (EX-HN 12), Yuye (EX-HN 13), Sishencong (EX-HN 1) and the twelve well-jing points, that use quick insertion of the tri-ensiform needles for bleeding. The needles are remained for 30 minutes every other day, three times a week.

As well as the western medicine standard therapy for 3 months and the secondary prevention treatment (the blood pressure control, platelet aggregation, glucose control, etc) for 6 months.

Group B:
Received the treatment of the standard therapy - the intracranial pressure (ICP) control, the blood pressure control, platelet aggregation, routine physiotherapy and occupational therapy, the secondary prevention treatment as well.

Joint Sponsor:
Beijing Hospital of Traditional Chinese Medicine (China)
No. 23 Meishuguanhoujie
Dongcheng District
Beijing 100010
China
T: +86 (0)10 5217 6852
F: +86 (0)10 5217 6808
Email: postmaster@bjzhongyi.com
Website: http://www.bjzhongyi.com

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Barthel Index (BI)
2. Stroke-Specific Quality Of Life (SS-QOL)

Assessments will be conducted at the baseline and at week 4, 12 and 24 follow-up.

Secondary outcome measures

1. The National Institutes of Health Stroke Scale (NIHSS)
2. Modified Rankin Scale (mRS)

Assessments will be conducted at the baseline and at week 4, 12 and 24 follow-up.

Overall trial start date

01/09/2009

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Stroke Patients were diagnosed according to criteria of cerebral arterial thrombosis in Western medicine and the criteria of apoplexy in Chinese medicine
2. The stroke patients were hospitalised because of the acute cerebral arterial thrombosis, that occurred in 10 days
3. Male or female, aged 40 - 75 years
4. National Institutes of Health Stroke Scale (NIHSS) grade from 4 to 21
5. Glasgox Coma Score greater than or equal to 7
6. Patients on the first attack or with a cerebral stroke history but with on serious deformity, modified Rankin Scale (mRS) grade less than or equal to 1
7. Patients who took part in the trail voluntarily and signed the informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

328

Participant exclusion criteria

1. Patients under the treatment of thrombolysis
2. Patients under other clinical trials, or having undergone other clinical trials in the last 3 months
3. Patients with severe primary diseases in cardiovascular system, liver, kidney, hematopoietic system, and psychopathy
4. Pregnant women or women in breast feeding period
5. Inborn handicaps

Recruitment start date

01/09/2009

Recruitment end date

30/06/2012

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine
Beijing
100010
China

Sponsor information

Organisation

Beijing Municipal Science and Technology Commission (China)

Sponsor details

No. 16 Xizhimendajie
Xicheng Dis.
Beijing
100035
China
+86 (0)10 6615 3395
bjkwwz@sina.com

Sponsor type

Government

Website

http://www.bjkw.gov.cn/n1143/index.html

Funders

Funder type

Government

Funder name

Beijing Municipal Science and Technology Commission (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Beijing Hospital of Traditional Chinese Medicine (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23145765

Publication citations

  1. Protocol

    Liu H, Zhang D, Tan X, Yang D, Wang G, Zhao Y, Wen Y, Shi G, Wang L, The effect of acupuncture on stroke recovery: study protocol for a randomized controlled trial., BMC Complement Altern Med, 2012, 12, 216, doi: 10.1186/1472-6882-12-216.

Additional files

Editorial Notes