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Trial registered on ANZCTR


Registration number
ACTRN12612001181897
Ethics application status
Approved
Date submitted
22/10/2012
Date registered
7/11/2012
Date last updated
1/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the efficacy and safety of a Chinese herbal medicine formula in the management of eczema (atopic dermatitis) in children
Scientific title
Evaluation of the efficacy and safety of a Chinese herbal medicine formula (RCM-106) in the management of atopic dermatitis in children: A randomised placebo-controlled clinical trial
Secondary ID [1] 281419 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic dermatitis 287668 0
Condition category
Condition code
Alternative and Complementary Medicine 288008 288008 0 0
Herbal remedies
Skin 288009 288009 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Chinese herbal formula, RCM-106 capsules (Each capsule contains herbal extracts of the Chinese herbs Fang Feng 75mg, Chao Bai Zhu 75mg, Ku Shen 75mg, Sheng Di Huang 100mg, Bai Shao 50mg, Gan Cao 50mg, Bai Xian Pi 75mg); each capsule weighs 500mg; dosage of 3 capsules twice a day (6 capsules per day) for participants aged 6-11 and 6 capsules twice a day (12 capsules per day) for participants aged 12-18 years old; treatment duration of 8 weeks
Intervention code [1] 285913 0
Treatment: Other
Comparator / control treatment
Arm 2: Placebo capsules consisting of herbal starch with no active ingredients (each capsule weighs 500mg); dosage of 3 capsules twice a day (6 capsules per day) for participants aged 6-11 and 6 capsules twice a day (12 capsules per day) for participants aged 12-18 years old; treatment duration of 8 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 288219 0
Primary Outcome 1: Severity and improvement of atopic dermatitis using the validated instrument, SCORing Atopic Dermatitis (SCORAD).
Timepoint [1] 288219 0
Timepoint: at baseline (during initial assessment), after wash-out period prior to intervention commencement (week 1), weeks 3, 5, 7 and 9.
Primary outcome [2] 288220 0
Primary Outcome 2: mean Patient-oriented SCORAD (PO-SCORAD).
Timepoint [2] 288220 0
Timepoint: at baseline (during initial assessment), after wash-out period prior to intervention commencement (week 1), weeks 3, 5, 7 and 9, and after 4 weeks' follow-up period (week 13).
Secondary outcome [1] 299629 0
Secondary Outcome 1: Quality-of-life scoring using the Children's Dermatology Life Quality Index (CLDQI).
Timepoint [1] 299629 0
Timepoint: at baseline (during initial assessment), after wash-out period prior to intervention commencement (week 1), weeks 3, 5, 7 and 9, and after 4 weeks' follow-up period (week 13).
Secondary outcome [2] 299630 0
Secondary Outcome 2: Occurrence of adverse events - self-reported by participants using a daily diary. Examples of adverse events may include nausea, vomiting, gastrointestinal upsets, headache, dizziness, or various dermatoses.
Timepoint [2] 299630 0
Timepoint: Daily diary will be reviewed every 2 weeks from commencement of wash-out period (2 weeks prior to week 1) until the completion of treatment period at week 9.
Secondary outcome [3] 299631 0
Secondary Outcome 3: Usage of other therapies during the duration of the trial - self-reported by participants using a daily diary.
Timepoint [3] 299631 0
Timepoint: Daily diary will be reviewed every 2 weeks from commencement of treatment period (week 1) until the completion of treatment period at week 9.
Secondary outcome [4] 299632 0
Secondary Outcome 4: Safety profiles - Blood tests (full blood count, eosinophil count, and total IgE), liver function test and kidney function test.
Timepoint [4] 299632 0
Timepoint: at baseline and after treatment period at week 9.

Eligibility
Key inclusion criteria
*Diagnosed with atopic dermatitis according to the UK Diagnostic Criteria; *Has moderate-to-severe AD (SCORAD index of 25 or more) *Aged between 6 to 18 years old; *Agree to abstain from alcohol during the period of the trial; *Not involved in other clinical trials; *Agree to avail themselves for the period of the study; *Provide written consent for participation from parent or legal guardian and verbal consent from the participant; and *Pass the "swallow-test" (able to swallow an empty size #1 capsule) during the initial assessment or willing to undergo "capsule-swallowing training program".
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Presence of overt bacterial infection/concurrent systemic disease (except asthma and allergic rhinitis); *Pregnant/intention to get pregnant/breastfeeding/females of childbearing age refusing contraception; *Unable to swallow size #1 capsules (approximately 19.4mm in length and 6.41mm in diameter) and refuse to undergo "capsule-swallowing training program"; *Has history of sensitivity towards Chinese herbal medicine; *Has abnormal full blood count (with the exception of parameters related to AD, such as eosinophil count and total IgE), renal or liver function tests; *Usage of Chinese herbs, systemic steroids, antibiotics, phototherapy or any immune-modulating drugs 4 weeks prior to the study; *Using other therapies (except for the use of topical therapies when necessary); and *Unable to understand English.

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)
Allocation concealment will be done using treatment codes generated by an independent statistician. Placebo and RCM-106 capsules will be made to be identical in appearance and scent, and will be pre-packaged identically. The codes and labeling will be recorded in a password protected computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will be responsible for randomisation and ensure the comparability in both groups. Block randomised sequences according to diseases severity will be generated using a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/04/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286184 0
Self funded/Unfunded
Name [1] 286184 0
Country [1] 286184 0
Primary sponsor type
University
Name
RMIT University
Address
RMIT University
GPO Box 2476
Melbourne VIC 3001
Country
Australia
Secondary sponsor category [1] 284994 0
None
Name [1] 284994 0
Address [1] 284994 0
Country [1] 284994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288256 0
RMIT University Human Research Ethics Committee (HREC)
Ethics committee address [1] 288256 0
RMIT University Human Research Ethics Committee (HREC)
RMIT University
GPO Box 2476
Melbourne, VIC 3001
Ethics committee country [1] 288256 0
Australia
Date submitted for ethics approval [1] 288256 0
Approval date [1] 288256 0
26/09/2012
Ethics approval number [1] 288256 0
15/12/2012

Summary
Brief summary
Atopic dermatitis, or eczema, is a chronic, inflammatory, itchy skin disease that affects 15-30% of children and 2-10% of adults. This condition is highly distressing and affects the quality-of-life of its sufferers and their families. Unfortunately, there is currently no adequate treatment for atopic dermatitis.
Traditional Chinese medicine has had a long history of treating various conditions, including skin conditions such as atopic dermatitis. However, evidence is lacking. In attempt to find a better form of management for atopic dermatitis, we have formulated a new Chinese herbal formula, RCM-106, using Western and Chinese medicine theories. It is anticipated that RCM 106 would be able to reduce the severity of atopic dermatitis and possibly improve the quality-of-life of sufferers.
The efficacy and safety of RCM-106 will be evaluated in a randomised, double-blind, placebo-controlled clinical trial. Participants of the trial have a 50-50 chance of being allocated to receive RCM-106 capsules or the inactive placebo capsules for 8 weeks. The progression of participants’ atopic dermatitis will then be observed and recorded to see how well RCM-106 works. Positive results from the trial may result in a better form of treatment for atopic dermatitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34855 0
Dr George Lenon
Address 34855 0
School of Health Sciences RMIT University PO Box 71 Bundoora VIC 3083
Country 34855 0
Australia
Phone 34855 0
+61 3 9925 6587
Fax 34855 0
Email 34855 0
[email protected]
Contact person for public queries
Name 18102 0
Dr. George Lenon / Hsiewe Ying (Amy) Tan
Address 18102 0
School of Health Sciences
RMIT University
PO Box 71
Bundoora VIC 3083
Country 18102 0
Australia
Phone 18102 0
+61 3 9925 6587 / +61 3 9925 7635
Fax 18102 0
+61 3 9925 7178
Email 18102 0
[email protected] / [email protected]
Contact person for scientific queries
Name 9030 0
Dr. George Lenon / Hsiewe Ying (Amy) Tan
Address 9030 0
School of Health Sciences
RMIT University
PO Box 71
Bundoora VIC 3083
Country 9030 0
Australia
Phone 9030 0
+61 3 9925 6587 / +61 3 9925 7635
Fax 9030 0
+61 3 9925 7178
Email 9030 0
[email protected] / [email protected]

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