Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00435

2 Trial Registration Date

2014-10-20

iRegistration Status

Prospective

3 Secondary IDs

ICM\CTS\13\353

4 Source(s) of Funding

ITF

5 Primary Sponsor

Dept of Orthopaedics & Traumatology, CUHK

6 Secondary Sponsor

Institute of Chinese Medicine

Function

Please specify

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

i Name

Ellie Pang

ii Address

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

iii Phone

2252-8863

iv Email

elliepang@cuhk.edu.hk

v Affiliation

Institute of Chinese Medicine, CUHK

vi Country

8Research 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

26322723

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 Nano Herbal Preparation for the Treatment of Plantar Fasciitis

10 Public Title

A Pilot Study on the Effectiveness of a Nano Herbal Preparation for the Treatment of Plantar Fasciitis

i Public Title in Chinese 研究名稱

使用纳米消炎贴治療足底筋膜炎

11 Short Title (Optional)

Nano patch for Plantar Fasciitis

12 Countries of Recruitment

HKSAR

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-09-19

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Plantar Fasciitis

15Intervention

i Types of intervention

Other

Please specify

A topical herbal patch

ii Description/ name of Intervention/article

A nano 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

16Comparative Treatments

i Description/ name of comparative treatments

Single Arm, 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

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

-Unilateral or bilateral plantar fasciitis
-Male and female volunteers
-Aged between 18 and 65 years old
-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
-Local injection of steroidal compounds for treating plantar fasciitis in the past 30 days,
-History of adhesive bandage hypersensitivity
-Neurological abnormalities, nerve entrapment (for example, tarsal tunnel syndrome)
-In the judgment of the investigator, unable to comply with the protocol requirements
-Pregnancy or breast feeding

iii Age Minimum

18

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19Study 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

2014-11-10

21 Target Sample Size

10

22 Recruitment Status

Complete

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

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2015-08-27

27 Primary Registry and Trial Identifying Number

ChiCTR-OPB-15006637

28 Date of Registration in Primary Registry

2014-10-20

Back History

Trial Detail