Acute upper respiratory tract infection with fever (syndrome of external cold and internal heat)
Conditions
Interventions
Experimental group:Xiaoer Chaigui antipyretic oral liquid + Xiaoer cold Shu granule simulator
Control group:Xiaoer Chaigui antipyretic oral liquid simulator + Xiaoer Ganshu granules
Sponsors
The First Affiliated Hospital of Tianjin University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 14 Years
Inclusion criteria
Inclusion criteria: (1) meet the Western diagnostic criteria for acute upper respiratory tract infection(According to the 9th edition of "Zhufutang Practical Pediatrics" and the 9th edition of "Pediatrics" People's Medical Publishing House, the diagnosis can be combined with symptoms, signs and laboratory examination); (2) in line with the standard of TCM cold outward cold inner heat syndrome differentiation(It can be diagnosed by referring to the Technical Guidelines for the Design and Evaluation of Clinical Trials of Traditional Chinese Medicine for Pediatric Series of Common Diseases · Acute Upper Respiratory Tract Infection and TCM Diagnostics (The 13th Five-Year Plan 10th Edition), combined with tongue and pulse fingerprint of primary and secondary syndromes); (3) 1 year = age =14 years; (4) Duration of disease =36h and maximum body temperature =37.3? within 24h before treatment; (5) The informed consent process shall comply with regulations
Exclusion criteria
Exclusion criteria: (1) Diagnosed as fever of pharyngeal conjunctival membrane, herpetic angina, suppurative tonsillitis, suppurative middle ear Children with inflammation, bronchitis, bronchiolitis, pneumonia, influenza and other diseases; (2) Diagnosed as infantile-acute rash, measles, scarlet fever, epidemic cerebrospinal meningitis, whooping cough, ridge Children with poliomyelitis and other infectious diseases; (3) Patients with severe malnutrition, rickets and complicated heart, brain, liver, kidney and hematopoietic system severe Children with severe primary diseases; (4) Blood creatinine (SCr) and urea nitrogen can not be explained by the tested disease or combined disease conditions (BUN) and glutamic-pyruvic aminotransferase (ALT) increased, as well as urine protein, urine red blood cell "+" above; (5) Allergic to known components of the investigational drug; (6) Have participated in other clinical trials or are participating in other drug clinical trials within the last 3 months; (7) Those who were not considered suitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CARIFs comprehensive symptom dimension recovery rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate in CARIFs symptom dimension;TCM syndrome efficacy (comprehensive symptom efficacy, single symptom efficacy);Children's 5-dimensional Health Scale (EQ-5D-Y) score difference;Onset time of fever (h);Time to complete regression (h);Use of antipyretic and analgesic drugs;Complication rate; | — |
Countries
China
Contacts
Public ContactLi Xinmin
The First Affiliated Hospital of Tianjin University of Chinese Medicine
Outcome results
None listed