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 childre

Phase 4

Not yet recruiting

• Conditions: acute pharyngitis and tonsillitis in children

• Registration Number: ITMCTR2000003177
• Lead Sponsor: The First Teaching Hospital of Tianjin University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified