Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00339

2 Trial Registration Date

2012-10-10

i Registration Status

Prospective

3 Secondary IDs

Nil.

4 Source(s) of Funding

Chinese Medicine Department, Hospital Authority, Hong Kong.

5 Primary Sponsor

School of Chinese Medicine, CUHK

6 Secondary Sponsor

1. Pok Oi Hospital – The Chinese University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine (Shatin);
2. Pok Oi Hospital – The Chinese University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine (Yuen Long); and
3. Yan Oi Tong Chinese Medicine Polyclinic cum The Chinese University of Hong Kong Chinese Medicine Clinical Training and Research Centre.

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Professor Zhi-Xiu Lin.

ii Address

School of Chinese Medicine, 1/F. Sino Building, CUHK, Shatin, N.T.

iii Phone

39436347

iv Email

linzx@cuhk.edu.hk

v Affiliation

School of Chinese Medicine, CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Professor Zhi-Xiu Lin

ii Address

School of Chinese Medicine, 1/F., Sino Building, CUHK, Shatin, N.T.

iii Phone

39436347

iv Email

linzx@cuhk.edu.hk

v Affiliation

School of Chinese Medicine, CUHK

vi Country

9 Official Scientific Title of the Study

Effectiveness of Acupuncture for the Treatment of Post-Stroke Dysphagia: A Pragmatic Trial Comparing Real Acupuncture Treatment with Waiting List

10 Public Title

Effectiveness of Acupuncture for the Treatment of Post-Stroke Dysphagia: A Pragmatic Trial Comparing Real Acupuncture Treatment with Waiting List

i Public Title in Chinese 研究名稱

針刺治療中風後吞嚥困難的臨床試驗研究

11 Short Title (Optional)

Acupuncture for Post-Stroke Dysphagia

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-07-18

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Post-stroke dysphagia

15 Intervention

i Types of intervention

Other

Please specify

Acupuncture

ii Description/ name of Intervention/article

Acupuncture treatment under the guidance of Chinese medicine theory

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Three times a week for two months.

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

The conventional supportive and rehabilitative treatment will be provided in the control group.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

• Age between 30-70 years old;
• With an ischemic stroke confirmed by a CT scan;
• Fulfil RBHOMS with 5 points or above with modified diet;
• Within 6 months after the first or second stroke; and
• Able to give informed consent.

ii Exclusion Criteria

• Dysphagia induced by a hemorrhagic stroke;
• Dysphagia caused by head injury or neurological disease other than stroke;
• Unstable cardiac arrhythmia;
• Life threatening infection;
• Unconsciousness or severe cognition deficits;
• Oral or throat diseases that display dysphagia;
• Patients with bleeding tendencies or thrombocytopenia, who are taking anticoagulants, or have advanced malignancy.

iii Age Minimum

30 years old

iv Age Maximum

70 years old

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-01-01

21 Target Sample Size

140

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS)

24 Secondary Outcome

(1) Swallow function scores, a 7-point scale that describes the severity of swallowing dysfunction;
(2) Swallow quality-of-life questionnaire in Chinese version.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-11-11

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil.

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Trial History Detail on 2012-10-10