None listed
Conditions
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.
Interventions
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
Sponsors
RMIT University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Healthy volunteers
No
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".
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.
Outcome results
None listed