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Clinical Trials/ACTRN12614001172695
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.

Investigators

Sponsor
RMIT University, Australia

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