Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00380

2 Trial Registration Date

2013-10-11

i Registration Status

Prospective

3 Secondary IDs

ICM\CTS\13\354

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, 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 on the Effectiveness of a Novel Herbal patch for the Treatment of Plantar Fasciitis

10 Public Title

A Pilot Study on the Effectiveness of a Novel Herbal patch for the Treatment of Plantar Fasciitis

i Public Title in Chinese 研究名稱

使用中藥抗炎霜治療足底筋膜炎

11 Short Title (Optional)

Novel Herbal Patch for Plantar Fasciitis

12 Countries of Recruitment

HKSAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-10-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Plantar Fasciitis

15 Intervention

i Types of intervention

Other

Please specify

A topical herbal patch

ii Description/ name of Intervention/article

A novel herbal patch

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

-Unilateral or bilateral plantar fasciitis
-Male and female volunteers
-Ages of 18 or above
-Had plantar fasciitis of one or both feet for more than 30 days
-Signed informed consent

ii Exclusion Criteria

-Patients with ulcerations
-Allergic to herbs
-Treatment of the condition by a physician, physical therapist, or chiropractor within the last 30 days,
-Dysfunction of foot or ankle (for example, instability)
-Arthrosis or arthritis of the foot
-Infections or tumors of the lower extremity
-Neurological abnormalities, nerve entrapment (for example, tarsal tunnel syndrome)
-Vascular abnormality (for example, severe varicosities, chronic ischemia)
-Operative treatment of the heel spur
-Pregnancy

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

2013-10-25

21 Target Sample Size

10

22 Recruitment Status

Recruiting

23 Primary Outcome

State of local pain at the end of 6 weeks’ topical treatment assessed by Ultrasound imaging, Pain Scales, Questionnaire.

24 Secondary Outcome

Image changes of the plantar fascia after treatment and inflammation marker at 6 weeks.

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

ChiCTR-OCS-13003674

28 Date of Registration in Primary Registry

2013-10-11

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2013-10-23