Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00379

2 Trial Registration Date

2013-10-11

i Registration Status

Prospective

3 Secondary IDs

ICM\CTS\13\355

4 Source(s) of Funding

ITF

5 Primary Sponsor

Dept of Orthopaedics & Traumatology, CUHK

6 Secondary Sponsor

Institute of Chinese Medicine

Function

Please specify

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

i Name

Dr. Ernie Fung

ii Address

Institute of Chinese Medicine, 5/F, School of Public Health Building, PWH

iii Phone

2252-8863

iv Email

fungchakhei@cuhk.edu.hk

v Affiliation

Institute of Chinese Medicine, CUHK

vi Country

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

i Name

Prof. Leung Kim HUNG

ii Address

Room 74038, 5/F, Lui Che Woo Clinical Sciences Building, PWH

iii Phone

2632 2723

iv Email

leungkimhung@cuhk.edu.hk

v Affiliation

Dept. of Orthopaedics & Traumatology, CUHK

vi Country

9 Official Scientific Title of the Study

A Pilot Study of the Effectiveness of a Novel Herbal Bath for the Treatment of Acute Ankle Sprain Injury

10 Public Title

A Pilot Study of the Effectiveness of a Novel Herbal Bath for the Treatment of Acute Ankle Sprain Injury

i Public Title in Chinese 研究名稱

使用中藥治療足裸扭傷

11 Short Title (Optional)

Novel Herbal Bath for Acute Ankle Sprain Injury

12 Countries of Recruitment

HKSAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-10-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Acute Ankle Sprain Injury

15 Intervention

i Types of intervention

Other

Please specify

Topical Herbal Bath

ii Description/ name of Intervention/article

A topical herbal bath

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Maximum 6 weeks or until pain disappears

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Single Arm study, no comparative treatment

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

-18 years of age or above with skeletal maturity
-Male or female patients attending Trauma or Sport Clinics at Prince of Wales Hospital
-Acute foot & ankle injury (soft tissue injury) without fracture within 2 weeks after injury
-No previous ankle injury or operation

ii Exclusion Criteria

-patient with open wounds
-plain radiograph showed ankle fracture

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-10-24

21 Target Sample Size

10

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

State of local pain at the end of 6 weeks’ topical treatment by ultrasound and ScanGogh & Foot and ankle Scoring system pre-post comparison.

24 Secondary Outcome

Image and inflammation changes after 6 weeks treatment

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-08-13

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

NA

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Trial History Detail on 2013-10-11