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)

The First Teaching Hospital of Tianjin University of TCM0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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.

发起方

The First Teaching Hospital of Tianjin University of TCM