Study topic：A comparative effectiveness research on Jinyebaidu granule in treating patients with acute upper respiratory infection: A double blind, double dummy, randomized, controlled trial. It is a post-marketing clinical study to evaluate effectiveness, safety and cost-effectiveness on Jinyebaidu granule in treating acute upper respiratory infection. Objectives of Study：This study aims to evaluate effectiveness, safety and cost-effectiveness on Jinyebaidu granule in treating patients with acute upper respiratory infection. Study design：multi-center double-blind, double-dummy, randomized, controlled trial
1. Inclusion criteria * Patients diagnosed as acute upper respiratory infection. * Patients with acute upper respiratory infection diagnosed as Traditional Chinese Medicine(TCM) syndrome wind-heat attacking the Lung (type of heat pathogen invading the defensive Qi of the lung). * Acute upper respiratory infection onset time is less than 36 hours. * Patients aged 18 to 70 years old. * Patients agreed to participate this study and sign the informed consent. 2. Effectiveness evaluation * TCM symptoms: fever, sore throat, cough with or without expectoration, headache, thirst, change of tongue body, tongue coating and pulse. * Signs: swollen tonsils, pharyngeal hyperemia. * Body temperature 3. Safety evaluation * Clinical symptoms and signs of adverse event reaction * Signs: blood pressure, respiration, heart rate, body temperature; * Routine blood test and urine routine; * Liver function and renal function: Alanine transaminase (ALT)、glutamic-oxalacetic transaminease(AST)、serum creatinine(SCr)、urea nitrogen(BUN) ; * Incidence of electrocardiogram(ECG) abnormalities. 4. Cost-effectiveness evaluation cost calculation * The direct medical costs include: the registration expenses, examination expenses, laboratory test expenses, Treatment costs, Chinese medicine expenses, Chinese herbal medicine expenses, western medicine expenses; Indirect medical costs: transportation costs, lost income patients; Adverse drug reactions cost: the cost of treatment due to adverse drug reactions. * Effect Evaluation:Symptoms and signs score, physical examination, the incidence of complications. 5. Number of participants 600 participants will be divided into two groups, the experimental group (n=300)and the control group (n=300).Each group will be stratified into three layers according to fever, sore throat, fever and sore throats. 100 patients will be included in each level. 6. Dose regimen * treatment group: Jinyebaidu granule, blunt, 10g/time, three times a day; Compound Shuanghua granules placebo, blunt, 6g /time, 4 times a day. * Control group: Compound double flowers particles, blunt, 6g/time, 4 times a day; Jinyebaidu Granule placebo, blunt, 10g/time, three times a day. 7. Course of treatment：5 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
It is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb.
It is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata.
It is Jinyebaidu granule placebo.
It is Fufangshuanghua granule placebo.
Guang'anmen Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe time to defervescence
Time frame: defined as the time from the first dose of study medication to the time when the body temperature declined to lower than 37.3ºC
Change of symptoms score
The symptoms includes sore throat, cough, expectoration, headache, thirst. According to severity ,each symptom include four grades. The scores of sore throat are 0,2,4,6. The scores of cough, expectoration ,headache, thirst are 0,1,2,3. Compare the change from baseline all of symptoms score at the third day and at the fifth day. References: Mao bing, Li ting-qian, Li ming-quan, Tu jin-wen, Zhang rui-ming, et al. Clinical randomized double--blinded observation on effect of Jinyebaidu Granule in treating the disease of wind-heat attacking the lung(type of heat pathogen invading the defensive Qi of the lung). chinese JounIal of Evidence-Based Medicine Jun, 2003,3(2):115-120
Time frame: change from baseline symptoms score at the third day and at the fifth day
Change of signs score
The signs includes swollen tonsils and pharyngeal hyperemia. According to severity, each sign includes four grades. The scores are 0,4,6,8. References: Mao bing, Li ting-qian, Li ming-quan, Tu jin-wen, Zhang rui-ming, et al. Clinical randomized double--blinded observation on effect of Jinyebaidu Granule in treating the disease of wind-heat attacking the lung(type of heat pathogen invading the defensive Qi of the lung). chinese JounIal of Evidence-Based Medicine Jun, 2003,3(2):115-120
Time frame: change from baseline signs score at the fifth day
Adverse events
Time frame: All the time in the study
Change of routine blood test
The routine blood test includes white blood cell count, neutral cell ratio, lymphocyte ratio, single nuclear cell ratio, red blood cell count, hemoglobin, platelet count
Time frame: Change from base line, on the fifth day
Change of urine routine
The urine routine includes white blood cell count, red blood cell count,urine protein,urine sugar
Time frame: Change from base line, on the fifth day
Change of liver function
The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase
Time frame: Change from base line, on the fifth day
Change of renal function
The renal function includes creatinine,usea nitrogen
Time frame: Change from base line, on the fifth day
Incidence of ECG abnormalities
Time frame: Change from base line, on the fifth day
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