A Randomized, Controlled, Multicenter Clinical Study on the Effectiveness of Xiao'er Jiebiao oral liquids in the Treatment of Influenza in Childre
- Conditions
- Influenza in Children
- Registration Number
- ITMCTR2000003909
- Lead Sponsor
- Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients diagnosed with influenza A (H1N1, H3N2) or influenza B virus according to real-time polymerase chain reaction (PCR) or virus culture;
2. Patients aged 5 to 14 years old;
3. Patients with axillary temperature = 38 ?;
4. Patients with at least two general symptoms (headache, chills, myalgia or fatigue) and one respiratory symptom (cough, sore throat or rhinitis);
5. Patients who meet the diagnostic criteria of TCM syndromes;
6. Patients with a course of disease within 72 hours;
7. Patients with written informed consent.
1. Patients with bronchitis, pneumonia, pleural effusion and interstitial lung disease on chest X-ray;
2. Patients with bacterial infection indicated by blood routine examination;
3. Patients with suppurative tonsillitis or purulent sputum;
4. Patients with primary diseases, such as blood diseases, bronchial asthma, liver diseases, kidney diseases, chronic congestive heart failure and nervous system diseases;
5. Patients who had taken antiviral drugs (amantadine, rimantadine, zanamivir or oseltamivir phosphate) before the onset and enrollment of the study, or took Chinese herbal medicine or proprietary Chinese medicine.
6. Patients allergic to the study drug;
7. Patients who have taken immunosuppressants in the last 3 months;
8. Patients who participated in another clinical trial within 3 months before participating in this trial;
9. Patients with acute respiratory tract infection, otitis or sinusitis 2 weeks before enrollment;
10. Patients who have been vaccinated with influenza vaccine within 6 months;
11. Other reasons considered by the researchers.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of disease;The rate of cure;TCM syndrome score;
- Secondary Outcome Measures
Name Time Method Frequency of use of antipyretic;Incidence of influenza complications;Defervescence time;Disease severity;Negative conversion rate of influenza virus;