Condition category
Circulatory System
Date applied
24/09/2010
Date assigned
19/10/2010
Last edited
19/10/2010
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 Linpeng 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 both acupuncture and moxibustion versus standard Western therapy in reducing the rate of deformity of stroke and in improving the symptoms of urination disorders after stroke in adult patients: a multicentre randomised controlled trial

Acronym

EAMUDS

Study hypothesis

Stroke can lead to the urination disorders, for instance, urinary incontinence, urgency of urination and urinary frequency. Urination disorders may severely influence the patients' quality of life and contribute to the burden of medical care. This study is to explore the acupuncture and moxibustion in improving the symptoms of urination disorders after stroke and the quality of the patients' lives.

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 single blind 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 120 patients in the recovery stage of cerebral apoplexy will be recruited. All of the 120 patients are from the Acupuncture Department of Beijing Huguosi Chinese Medicine Hospital and the Acupuncture Department of Beijing Hospital of Traditional Chinese Medicine. 60 patients fit the description for the syndrome of deficiency of kidney-yang and 60 patients fit the description for the syndrome of deficiency of qi.

1. The patients with the syndrome of deficiency of kidney-yang were randomly divided into two different groups with the ratio of 2:1.
1.1.The experimental group (A) received the acupuncture and moxibustion remedy for 4 weeks:
Cut the fresh ginger into slices (thickness 6-7mm, diameter 40-50mm), pierce several holes on the ginger. Put the mugwort floss (height 30mm, diameter 30mm, column) on the slices of gingers. Fill the salt in Shenque (RN-8) and place the slice of ginger on Shenque, light the mugwort floss, until it burnout, for 3 zhuangs, once a day, five days a week.
1.2. The patients of the controlled group (B) wait for 4 weeks with no therapy.

2. The patients with the syndrome of deficiency of qi were randomly divided into two different groups with a ratio of 2:1.
2.1. The experimental group (C) received the electro acupuncture remedy for 4 weeks:
Needling Ciliao (BL-31) and Huiyang (BL-35), on both sides of the body. Oblique insertion into the 2nd posterior sacral foramina to depth of 80mm, with electrified needling sensation to external genitalia. Perpendicular needling in Huiyang, if a sore and distended needling response then lift the needles a little, link up the electric impulse acupuncture units, choose frequency 50 hz. Gently adjust the frequency as much as the patients can endure, apply the needles for 30 minutes, once a day, five days a week.
2.2. The patients of the controlled group (D) wait for 4 weeks with no therapy.

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

The number of incontinence and normal micturition episodes in 72 hours. Assessed by a micturition diary over 4 weeks.

Secondary outcome measures

1. Questionnaire of Overactive bladder (OAB) and incontinence at 4 weeks
2. Urinary incontinence grade score at 4 weeks
3. Quality of life assessment (Barthel Index) at 4 weeks

Overall trial start date

01/08/2009

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Stroke Patients diagnosed according to criteria of cerebral arterial thrombosis in Western medicine and the criteria of apoplexy in Chinese medicine
2. Inpatients who suffered a stroke in the previous 4-24 weeks
3. Male or female, aged 40-70
4. Fit the description for the syndrome of deficiency of kidney-yang or the syndrome of deficiency of qi
5. Urination disorders occuring after the stroke, and the patients' condition is stable
5.1. Patients that suffer from urinary incontinence; or
5.2. No urinary incontinence but with serious urgency of urination and increased urinary frequency
6. Patients with no disorder of consciousness, no barriers to communication
7. Patients with normal cognitive function

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Patients with severe primary diseases of the cardiovascular system, liver, kidney, hematopoietic system, psychopathy or late stage tumor
2. Patients with chronic retention of urine, urinary incontinence, urgency of urination and high frequency of urination before the stroke
3. Patients suffering from chronic urinary infection
4. Patients suffering from serious anepia, difficulty communicating or severe cognitive disorder which may result in urination disorder
5. Female with stress incontinence

Recruitment start date

01/08/2009

Recruitment end date

01/06/2012

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

Not defined

Website

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

Funders

Funder type

Hospital/treatment centre

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

Publication citations

Additional files

Editorial Notes