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Effectiveness of PeiTu QingXin (PTQX) Granules adds on usual care to reduce the accumulated relapse of the atopic dermatitis in children: A protocol for a multi-center, double-blind, randomized controlled trial

Effectiveness of PeiTu QingXin (PTQX) Granules adds on usual care to reduce the accumulated relapse of the atopic dermatitis in children: A protocol for a multi-center, double-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12003174
Enrollment
Unknown
Registered
2012-08-02
Start date
2013-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Atopic dermatitis

Interventions

experimental group:the Chinese medicine granules Pei Tu Qing Xin
Control group:Placebo

Sponsors

Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Screening criteria: 1. The aged from 2 to 12 years old; 2. Clinical diagnosis meets Hanifin and Rajka AD criteria; 3. IGA score is more than 2 (IGA score> 2); 4. The time without medication is less than 3 months each year; Inclusion criteria: 1. The age is from 2 to 12 years old; 2. Clinical diagnosis meets Hanifin and Rajka AD criteria; 3. The IGA score is less than 2 (IGA score > 2) after treatment of the screening period; 4. Informed consent (or by guardian for those minors).

Exclusion criteria

Exclusion criteria: 1. The patient is one of the investigators of this study; 2. Have used hormone or immunosuppressant in 2 week; 3. Patients can not complete the whole process of the study; 4. Have participated in other AD clinical trail in the current or a month ago; 5. Have significant abnormalities in the blood system, liver, kidney, heart and other system, or complicated with severe primary diseases of the cardiovascular, liver, kidney, brain and hematopoietic system; or suffering from mental disorders, malignant neoplasm; or combined with other skin disease; 6. Acute asthma exacerbation or other diseases that need to use hormone for the maintenance treatment.

Design outcomes

Primary

MeasureTime frame
The starting point of the relapse time;

Secondary

MeasureTime frame
To evaluate the major signs and subjective symptom;The Dermatitis Family Impact questionnaire;total amount of topical fluticasone propionate cream;

Countries

China

Contacts

Public ContactDa-can Chen
4910702@163.com+86 20 81887233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026