A Randomized, Controlled, Multicenter Clinical Study on The Effectiveness of Xiaoer Qinggan granules in The Treatment of Influenza in Childre
- Conditions
- Influenza in Children
- Registration Number
- ITMCTR2000003672
- Lead Sponsor
- Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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) Aged 5 to 14 years;
(3) Armpit temperature >= 38 degrees C;
(4) At least 2 systemic symptoms (headache, chills, myalgia or fatigue) and 1 respiratory symptom (cough, sore throat or rhinitis);
(5) Those who meet the diagnostic criteria of TCM syndromes;
(6) The course of the disease is within 72 hours;
(7) Sign a written informed consent.
(1) Bronchitis, pneumonia, pleural effusion and interstitial lung disease confirmed by chest imaging (x-ray examination or CT);
(2) Blood routine examination indicated bacterial infection;
(3) purulent tonsillitis or purulent sputum;
(4) Having primary diseases, such as blood diseases, bronchial asthma, liver diseases, kidney diseases, chronic congestive heart failure, and neurological diseases;
(5) Antiviral drugs (amantadine, rimantadine, zanamivir or oseltamivir phosphate) were taken before the onset and inclusion of the study, or Chinese herbal medicines or proprietary Chinese medicines were taken.
(6) Allergic to research drugs;
(7) Take immunosuppressants within the last 3 months;
(8) Participate in another clinical trial < 3 months prior to study randomization;
(9) Acute respiratory infection, otitis or sinusitis 2 weeks before study inclusion;
(10) Influenza vaccination within 6 months;
(11) Other reasons suggested by the researchers. See Table 4 for inclusion and exclusion criteria.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of cure;Defervescence time;Duration of disease;
- Secondary Outcome Measures
Name Time Method The time between the start of treatment and the return to normal life (kindergarten or school);Disease severity;TCM syndrome score;Incidence of influenza complications;Frequency of use of antipyretic;Negative conversion rate of influenza virus;