title: [Key technologies elements of clinical study of traditional Chinese medicine new drugs on children's dermatitis and eczema].
abstract: We assessed and graded the evidence of relevant systematic reviews and randomized controlled trials, combined with our clinical study practice to identify eleven key elements as a focus for the clinical study of traditional Chinese medicine (TCM) new drugs on children's dermatitis and eczema: the primary purpose and design of the study, the inclusion and exclusion criteria of the study, the treatment, the trail procedure,the effectiveness and safety evaluation, and quality control, etc, as well. In addition, seven recommendations for the design of clinical study of TCM new drugs on children's dermatitis and eczema were provided.
authors.affiliation: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. Clitripro@sina.com.cn
authors.forename: Cheng-Liang
authors.initials: CL
authors.lastname: Zhong
authors.forename: Chun
authors.initials: C
authors.lastname: Zhang
authors.forename: Si-Yuan
authors.initials: SY
authors.lastname: Hu
mesh_terms: D002648:Child; D002675:Child, Preschool; D003872:Dermatitis / Q000188:drug therapy*; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D004485:Eczema / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D010372:Pediatrics; D016032:Randomized Controlled Trials as Topic
chemical_list: D004365:Drugs, Chinese Herbal