A randomized, double-blind, dose exploration, multicenter phase II clinical trial: Evaluation of the efficacy and safety of Xiao'er Qingzhen Oral liquid in treatment of stage 1 of young child hand-foot-and-mouth disease (syndrome of toxin accumulating Qi and Ying)

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. Children who meet the stage 1 diagnostic criteria for hand, foot and mouth disease of western medicine;
•2. Children who accord with the syndrome differentiation standard of syndrome of toxin accumulating Qi and Ying;
•3. The maximum axillary temperature is >= 38 degree C 24h before treatment;
•4. Aged 1 ~ 6 years;
•5. Course of the disease is <= 24 hours;
•6. The legal guardian signs the informed consent voluntarily.

•1. Children with severe risk factors for HFMD included persistent high fever, nervous system manifestations, respiratory abnormalities, circulatory dysfunction, increased white blood cell count (>= 15 x 10^9/L), elevated fasting glucose ( > 8.3mmol/L), and elevated blood lactic acid ( >= 2.0mmol/L);
•2. Children with varicella/shingles, rubella, herpetic pharyngitis, atypical measles, cheeper urgent rash, and papular urticaria;
•3. Children with a history of febrile convulsions or seizures;
•4. Children with severe malnutrition, rickets and severe primary diseases of the heart, brain, lung, liver, kidney and hematopoietic system;
•5. Known or suspected to be allergic to the drug ingredients;
•6. The investigator considers it inappropriate to participate in this clinical trial.

发起方

The First Teaching Hospital of Tianjin University of TCM