a post-marketing research on jinyebaidu granule in treating patients with acute upper respiratory infection

Conditions: Acute Upper Respiratory Infection

Summary: 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

Eligibility criteria:
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. exclusion criteria: * patients diagnosed with suppurative tonsillitis (third degree), and chest x-ray imaging showed lung inflammation; * white blood cell counts more than 12 e9, neutrophils more than 80%, alt, ast, bun, cr more than 2 times of the normal upper limit; * patients with temperature lower than 37.5 degree centigrade, and without sore throat; * patients with temperature higher than 38.5 degree centigrade; * patients already receiving antibiotics or other similar drug treatment; * patients associated with other severe primary lung diseases, such as lung cancer, tuberculosis, pneumonia and other infectious diseases; * patients complicated with cardiovascular and cerebrovascular diseases, severe primary diseases of hematopoietic system, mental illness; * pregnant or lactating women; * patients with immunodeficiency resulted from organ transplantation, hiv / aids, or long-term use of immunosuppressive agents; * patients with drug allergy; * patients participating in other clinical trials, which influence outcome evaluation of the research.