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

RMIT University0 个研究点目标入组 90 人开始时间: 2012年11月7日最近更新: 2020年1月13日

适应症

试验速览

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•*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.

•*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.

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