Clinical trial of central randomized, double-blind, dose exploration, multi-center, and two-stage adaptive design to evaluate the immediate pain relief effect and safety caused by pediatric acute pharyngitis (wind heat syndrome)
- Conditions
- Treatment of acute pharyngitis in children
- Registration Number
- ITMCTR2200005988
- Lead Sponsor
- The Teaching Hospital of Tianjin University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the western diagnostic criteria for acute pharyngitis. 2.It conforms to the standard of wind-heat syndrome differentiation. 3.Duration =2 days. 4.VAS score =4 at initial diagnosis of sore throat (dysphagia). 5.Children aged 6-13 years (< 14 years) can correctly use VAS scoring tools.
6.The informed consent process should comply with the regulations, and the legal guardian or the subject child (=8 years old) should sign the informed consent.
1. Children or their parents/caregivers have difficulty in understanding or cooperating with the use of VAS. 2. At the time of initial diagnosis, the condition of the child is serious, such as lack of energy, restlessness, headache, or pain in body muscles, and antipyretic and analgesic drugs are needed. 3. Suppurative tonsillitis, abscess around tonsil or posterior pharyngeal wall, or white blood cell count, absolute value of neutrophil and CRP > ULN, which were considered to be caused by bacterial infection. 4.Children with measles, scarlet fever and other infectious diseases. 5.Children with acute laryngitis, otitis media, bronchitis, pneumonia and other complications. 6. Children with serious primary diseases of heart, lung, liver, kidney, metabolism, hematopoietic, immune, nervous, mental and other systems. 7. Allergic to the test drug (compound Solidago solidago spray) and its components, and allergic to antipyretic analgesics. 8.Patients who had taken acetaminophen, ibuprofen and other antipyretic and analgesic drugs within 6 hours before enrollment. 9.According to the judgment of the researcher, it is not suitable to be included in the group
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharyngeal pain;
- Secondary Outcome Measures
Name Time Method Effective rate of pharyngeal signs;Disappearance time/disappearance rate of pharyngeal pain.;TCM syndrome effect.;Recovery rates.;VAS score for sore throat.;Time and duration of immediate analgesic effect.;