ACTRN12614001172695CompletedPhase 2
A pilot study on the efficacy and safety of Chinese herbal medicine for children with moderate to severe atopic eczema
RMIT University, Australia0 sites30 target enrollmentStarted: November 7, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 6 Years to 16 Years (—)
- Sex
- All
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.
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.
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