A randomized, double-blind, dose-exploration, multi-center phase II clinical trial for the efficacy and safety of Peitu Qingxin (PTQX) Granules in the treatment of atopic dermatitis in children (heart fire and spleen deficiency syndrome)
- Conditions
- Atopic dermatitis
- Registration Number
- ITMCTR2000003901
- Lead Sponsor
- The First Teaching Hospital of Tianjin University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who meet the diagnostic criteria of atopic dermatitis;
2. Patients who meet the syndrome differentiation standard of heart fire and spleen deficiency;
3. Patients aged 6-12 years (< 13 years old);
4. SCORAD score <= 50, IgA score 2-3, total lesion area not less than 5% of body surface area;
5. The informed consent process should meet the requirements, and the guardian or the children (>= 8 years old) should sign the informed consent form.
1. Contact dermatitis, chronic simple lichen, psoriasis, ichthyosis, enteropathic acrodermatitis, neonatal acne, peritrichokeratosis, scabies, etc;
2. Patients with acute lesions accompanied by erosion, exudation or severe skin infection, or local skin lesions with severe bacterial, fungal or viral infection;
3. Children with acute asthma or those who need systemic hormone maintenance therapy;
4. Children who had been treated with glucocorticoid, immunosuppressive agents and ultraviolet rays within 4 weeks before enrollment, antihistamines within 2 weeks before enrollment and topical drugs (such as TCS and TCI) within 1 week before enrollment;
5. Patients with other serious systemic diseases such as cardiovascular, brain, liver, kidney and hematopoietic system;
6. Patients who are allergic to known ingredients of the test drug;
7. Patients who are considered unsuitable by the researchers.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SCORAD score;
- Secondary Outcome Measures
Name Time Method IGA score;Skin lesion recurrence;TCM syndrome score;CDLQI score;