A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection

NCT ID: NCT02539277


Title
A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection: A Double Blind, Double Dummy, Randomized, Controlled Trial
Purpose
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
Details
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
Conditions
Acute Upper Respiratory Infection
Keywords
Source
China Academy of Chinese Medical Sciences
Sponsors
China Academy of Chinese Medical Sciences, First Affiliated Hospital of Heilongjiang Chinese Medicine University, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing Hospital of Traditional Chinese Medicine, Changchun University of Chinese Medicine, Liaoning University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
Status
Recruiting
Acronym
Last Updated
01 Sep 2015
URL
Official Link
Locations
China