Randomised Double-blind Placebo-controlled Clinical Trial of Oral Ingestion of Chinese Herbal Medicine Granules for Children with Moderate to Severe Atopic Eczema (A pilot study)

Phase 2

Completed

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

• Registration Number: ACTRN12614001172695
• Lead Sponsor: RMIT University, Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome: skin lesion severity as assessed using Eczema Area and Severity Index (EASI) score.<br>[Baseline, 4, 8, 12 and 16 weeks. <br>]

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome 1: changes of symptoms assessed using the score of the patient-oriented eczema measure (POEM).<br><br>[Baseline, 4, 8, 12 and 16 weeks.];Secondary Outcome 2: changes of quality of life (QoL) assessed using the Children’s Dermatology Life Quality Index (CDLQI)<br><br>[Baseline, 4, 8, 12 and 16 weeks.];Secondary Outcome 3: usage of concomitant medications assessed using daily medical record.<br><br>[Baseline, 4, 8, 12 and 16 weeks.<br>];Secondary Outcome 4: Safety (laboratory tests including liver and renal function tests, FBE and IgE)<br><br>[Baseline, 4, 8, and 12 weeks.];Secondary Outcome 5: Safety (potential adverse events). Details of the adverse event will be recorded on Adverse Event Questionnaires)<br>[Baseline, 4, 8, 12 and 16 weeks.<br>]