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)

A pilot study on the efficacy and safety of Chinese herbal medicine for children with moderate to severe atopic eczema

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001172695

Acronym

PTQX trial

Enrollment

Registered

2014-11-07

Start date

2015-03-31

Completion date

2017-05-08

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The proposed project involves conduction of a randomised double-blind placebo-controlled clinical trial to test the efficacy and safety of oral ingestion of Chinese herbal medicine granules, PTQX for children with moderate to severe atopic eczema. The primary objective of this trial is to evaluate whether the oral ingestion of PTQX can reduce severity of the condition and improve the quality of life in children with moderate to severe AE. It will also assess the safety of PTQX for AE. The 16-week trial includes 12 weeks of treatment and a 4-week follow-up period.

Interventions

Chinese herbal medicine granules (Pei Tu Qing Xin PTQX) manufactured by Jiangyin Tianjiang Pharmaceutical Co. Ltd, China. Administration: oral ingestion. 4g twice daily for children age 6 to 7 years old and 6g twice daily for 8 to 16 years old for 12 weeks. A daily medical record sheet will be provided to monitor adherence to the intervention.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

6 Years to 16 Years

Healthy volunteers

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.

Outcome results