Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00084

2 Trial Registration Date

2005-09-26

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

HHSRF

5 Primary Sponsor

Department of Paediatrics

6 Secondary Sponsor

Institute of Chinese Medicine

Function

Please specify

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

i Name

Hon KL

ii Address

secretary Departmetn of Paediatrics

iii Phone

iv Email

v Affiliation

vi Country

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

i Name

Christy Kam

ii Address

secretary Departmetn of Paediatrics

iii Phone

iv Email

v Affiliation

vi Country

9 Official Scientific Title of the Study

A Randomized, Double-Blind, Placebo-Controlled Study of the Therapeutic Effect and Safety of a Traditional Chinese Medicine (TCM) for Atopic Dermatitis in Children

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2001-04-11

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Skin and Connective Tissue Diseases

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Use of TCM formulation

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

placebo

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

Inclusion: AD

ii Exclusion Criteria

Exclusion: active asthma oral steroids G6PDD

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

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

2004-10-01

21 Target Sample Size

80+

22 Recruitment Status

Complete

23 Primary Outcome

SCORAD

24 Secondary Outcome

steroid sue antihistamine use chemokine markers

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2005-09-26

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000734

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2011-02-08