A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children

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. Clinical diagnosis of acute pharyngitis/acute tonsillitis;
•2. Wind-heat syndrome or heat exuberance in lung and stomach syndrome in TCM;
•3. Wong-Baker FACES Pain Rating Scale (WBS) of immediate sore throat >=4 , body temperature <38.5 degrees C;
•4. Aged 4 to 12 years, can use WBS correctly;
•5. The informed consent process should be conducted in accordance with the regulations, and the legal guardian or the child (>=8 years old) shall jointly sign the informed consent.

•1. At the first diagnosis, the child's condition is more serious, and he/she suffers from poor mental state, irritability, headache, or limb muscle pain, and needs antipyretic and analgesic drugs;
•2. Children or their parents/caregivers have difficulty understanding or cooperating with the use of WBS;
•3. Children with peritonsillar or retropharyngeal abscesses, infectious mononucleosis, and measles and scarlet fever;
•4. Children with severe primary diseases of heart, lung, liver, kidney, metabolism, hematopoietic, immune, nervous and spiritual systems;
•5. Children with acute laryngitis, otitis media, bronchitis, pneumonia and other complications;
•6. Allergic to the experimental drug (KHJS) and its components, and allergic to antipyretic analgesics;
•7. Those who had taken acetaminophen, ibuprofen or other antipyretic analgesic within 6 hours before enrollment;
•8. Those who the researchers deemed unsuitable for the study.

发起方

The First Teaching Hospital of Tianjin University of TCM