Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00288

2 Trial Registration Date

2011-05-16

i Registration Status

Prospective

3 Secondary IDs

ICM/CTS/10/349

4 Source(s) of Funding

Institute of Chinese Medicine

5 Primary Sponsor

Institute of Chinese Medicine

6 Secondary Sponsor

Department of Orthopaedics & Traumatology, Kwong Wah Hospital
Social Hygiene Service, Department of Health
Dermatology Research Centre, Faculty of Medicine & Therapeutics, CUHK

Function

Please specify

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

i Name

Winnie Lo (Research Nurse)

ii Address

5/F, Institute of Chinese medicine, School of Public Health Building, Prince of Wales Hospital, Shatin, N.T.

iii Phone

2252 8863

iv Email

winnielo@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 Ping Chung

ii Address

5/F, Institute of Chinese medicine, School of Public Health Building, Prince of Wales Hospital, Shatin, N.T.

iii Phone

2252 8863

iv Email

pingcleung@cuhk.edu.hk

v Affiliation

Institute of Chinese Medicine, CUHK

vi Country

9 Official Scientific Title of the Study

Clinical Investigation of a two-herb recipe for the Treatment of Chronic Non-healing Ulcers

10 Public Title

Clinical Investigation of a two-herb recipe for the Treatment of Chronic Non-healing Ulcers

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Treatment of Chronic Non-healing Ulcers

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-05-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Chronic Non-healing Ulcers

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Chinese herbal medicine containing 2 herbs (Radix Rehmanniae and Radix Astragali)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

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

-Adult - over 18 years of age
-Have a chronic cutaneous ulcer resulting from causes like, venous stasis, leprosy, diabetes or arterial diseases.

ii Exclusion Criteria

-Have evidence of life threatening infection or cancer
-Pregnant woman

iii Age Minimum

18 years

iv Age Maximum

No maximum age limit

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

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

2011-05-23

21 Target Sample Size

50

22 Recruitment Status

Recruiting

23 Primary Outcome

Wound size: wound area reduction, time for wound closure

24 Secondary Outcome

Inflammation (Edema): Measurement of the leg circumferences at standard levels

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-08-27

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001358

28 Date of Registration in Primary Registry

2011-06-09

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-04-05