Evaluation of the efficacy and safety of a Chinese herbal medicine formula in the management of eczema (atopic dermatitis) in childre

Phase 2

Withdrawn

• Conditions: Atopic dermatitis; Alternative and Complementary Medicine - Herbal remedies; Skin - Dermatological conditions

• Registration Number: ACTRN12612001181897
• Lead Sponsor: RMIT University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: Severity and improvement of atopic dermatitis using the validated instrument, SCORing Atopic Dermatitis (SCORAD).[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: mean Patient-oriented SCORAD (PO-SCORAD).[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).]