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Trial registered on ANZCTR


Registration number
ACTRN12614001172695
Ethics application status
Approved
Date submitted
27/10/2014
Date registered
7/11/2014
Date last updated
24/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Double-blind Placebo-controlled Clinical Trial of Oral Ingestion of Chinese Herbal Medicine Granules for Children with Moderate to Severe Atopic Eczema (A pilot study)
Scientific title
A pilot study on the efficacy and safety of Chinese herbal medicine for children with moderate to severe atopic eczema
Secondary ID [1] 285338 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PTQX trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic eczema 293064 0
Condition category
Condition code
Alternative and Complementary Medicine 293338 293338 0 0
Herbal remedies
Skin 293339 293339 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chinese herbal medicine granules (Pei Tu Qing Xin PTQX) manufactured by Jiangyin Tianjiang Pharmaceutical Co. Ltd, China.
Administration: oral ingestion. 4g twice daily for children age 6 to 7 years old and 6g twice daily for 8 to 16 years old for 12 weeks.
A daily medical record sheet will be provided to monitor adherence to the intervention.
Intervention code [1] 290255 0
Treatment: Drugs
Comparator / control treatment
Placebo granules made of maltodextrins and lactose. The smell, colour and apparent package of placebo are as close as possible to PTQX.
Administration: oral ingestion. 4g twice daily for children age 6 to 7 years old and 6g twice daily for 8 to 16 years old for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 293168 0
Primary Outcome: skin lesion severity as assessed using Eczema Area and Severity Index (EASI) score.
Timepoint [1] 293168 0
Baseline, 4, 8, 12 and 16 weeks.
Secondary outcome [1] 310482 0
Secondary Outcome 1: changes of symptoms assessed using the score of the patient-oriented eczema measure (POEM).
Timepoint [1] 310482 0
Baseline, 4, 8, 12 and 16 weeks.
Secondary outcome [2] 310483 0
Secondary Outcome 2: changes of quality of life (QoL) assessed using the Children’s Dermatology Life Quality Index (CDLQI)
Timepoint [2] 310483 0
Baseline, 4, 8, 12 and 16 weeks.
Secondary outcome [3] 310484 0
Secondary Outcome 3: usage of concomitant medications assessed using daily medical record.
Timepoint [3] 310484 0
Baseline, 4, 8, 12 and 16 weeks.
Secondary outcome [4] 310485 0
Secondary Outcome 4: Safety (laboratory tests including liver and renal function tests, FBE and IgE)
Timepoint [4] 310485 0
Baseline, 4, 8, and 12 weeks.
Secondary outcome [5] 310486 0
Secondary Outcome 5: Safety (potential adverse events). Details of the adverse event will be recorded on "Adverse Event Questionnaires")
Timepoint [5] 310486 0
Baseline, 4, 8, 12 and 16 weeks.

Eligibility
Key inclusion criteria
I. Diagnosis of the condition:
a) History of skin pruritus in the last 12 months plus three or more of the any followings;
b) Onset under the age of two ;
c) History of flexural involvement;
d) History of a generally dry skin ;
e) Personal history of other atopic disease such as asthma
fe) Visible flexural dermatitis;
II. Severity of AE
The total score of NESS greater than or equals to 9 (moderate to severe) in baseline measurement;
III. Age: from 6 to 16 years old;
IV. Completion of informed consent form.
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Use of corticosteroids, other immunosuppressives, or any preparation of CHM or other herbal medicines for treatment of AE orally in the past 30 days;
b) Diagnosis of scabies, allergic contact dermatitis, seborrhoeic dermatitis or psoriasis;
c) Under six years or over 16 years old;
d) Severe medical conditions such as cardiovascular, liver or renal dysfunction;
e) History of lactose intolerance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through advertisement in local papers, posters, via the Internet, and through referrals from general practitioners (GPs) or dermatologists. Trial information flyers will be placed in offices of GPs or dermatologists who agree to refer patients to the trial.
The randomisation codes will be placed in sealed opaque envelopes. Participants will select an envelope, and hand it to the trial coordinator, who will write the participant details on the outside of the envelope. A number code inside the envelope will correspond with a package number that will contain either the intervention or placebo in identical packaging. Neither the trial participants nor investigators will know if the participant is receiving real treatment or placebo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocation will be to either the intervention group (PTQX) or control group (placebo) in equal ratio (1:1). Block randomisation method will be employed with a balanced variable blocks. Equal number of participants will receive the real treatment and the inert vehicle (the placebo). Randomisation codes will be generated by a computer program by an independent statistician who is not directly involved with the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be analysed by using Statistical Package for the Social Services (SPSS). Statistical analysis of continuous data will be made using one-way analysis of variance (ANOVA) for normally distributed data and non-parametric tests for skewed data. Chi-squared or Fisher’s exact test will be performed for comparison of dichotomous data. All comparisons will be made in 2-tailed and p-values < .05 is considered to be statistically significant. ITT analysis will be performed for missing data using the last observation carried forward (LOCF) method.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2014
Actual
31/03/2015
Date of last participant enrolment
Anticipated
30/09/2017
Actual
8/05/2017
Date of last data collection
Anticipated
31/12/2017
Actual
2/09/2017
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 7771 0
China
State/province [1] 7771 0
Guangdong

Funding & Sponsors
Funding source category [1] 289970 0
University
Name [1] 289970 0
China-Australia International Research Centre for Chinese Medicine and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University.
Country [1] 289970 0
Australia
Primary sponsor type
University
Name
RMIT University, Australia
Address
PO Box 71, Plenty Road, Bundoora Victoria 3083
Country
Australia
Secondary sponsor category [1] 288658 0
Hospital
Name [1] 288658 0
Guangdong Provincial Hospital of Chinese Medicine
Address [1] 288658 0
111 Da De Road, Guangzhou, Guangdong 510120
Country [1] 288658 0
China
Other collaborator category [1] 278157 0
Individual
Name [1] 278157 0
A/Prof Noel E Cranswick
Address [1] 278157 0
Royal Children's Hospital 50 Flemington Road, Parkville Victoria 3052
Country [1] 278157 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291680 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 291680 0
Ethics Officer, Research Integrity, Governance and Systems, RMIT University,
GPO Box 2476V VIC 3001
Ethics committee country [1] 291680 0
Australia
Date submitted for ethics approval [1] 291680 0
Approval date [1] 291680 0
05/06/2014
Ethics approval number [1] 291680 0
08/14
Ethics committee name [2] 300222 0
Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine
Ethics committee address [2] 300222 0
111 Dade Road, Guangzhou, Guangdong Province
Ethics committee country [2] 300222 0
China
Date submitted for ethics approval [2] 300222 0
11/12/2015
Approval date [2] 300222 0
20/01/2016
Ethics approval number [2] 300222 0
B2015-162-01

Summary
Brief summary
The proposed project involves conduction of a randomised double-blind placebo-controlled clinical trial to test the efficacy and safety of oral ingestion of Chinese herbal medicine granules, PTQX for children with moderate to severe atopic eczema.
The primary objective of this trial is to evaluate whether the oral ingestion of PTQX can reduce severity of the condition and improve the quality of life in children with moderate to severe AE. It will also assess the safety of PTQX for AE. The 16-week trial includes 12 weeks of treatment and a 4-week follow-up period.

Trial website
http://www.rmit.edu.au/healthsciences/eczema-trial
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51446 0
Prof Charlie Xue
Address 51446 0
School of the Health Sciences, RMIT University,
PO Box 71, Plenty Road, Bundoora Victoria 3083
Country 51446 0
Australia
Phone 51446 0
+61 3 9925 7360
Fax 51446 0
Email 51446 0
[email protected]
Contact person for public queries
Name 51447 0
Tony Zhang
Address 51447 0
Discipline of Chinese Medicine, School of the Health Sciences, RMIT University,
PO Box 71, Plenty Road, Bundoora Victoria 3083

Country 51447 0
Australia
Phone 51447 0
+61 3 9925 7758
Fax 51447 0
Email 51447 0
[email protected]
Contact person for scientific queries
Name 51448 0
Tony Zhang
Address 51448 0
Discipline of Chinese Medicine, School of the Health Sciences, RMIT University,
PO Box 71, Plenty Road, Bundoora Victoria 3083
Country 51448 0
Australia
Phone 51448 0
+61 3 9925 7758
Fax 51448 0
Email 51448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseChinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0806-y
EmbaseA Chinese herbal medicine preparation (Pei Tu Qing Xin) for children with moderate-to-severe atopic eczema: a pilot randomized controlled trial.2018https://dx.doi.org/10.1111/bjd.16988
N.B. These documents automatically identified may not have been verified by the study sponsor.