A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection
A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection: A Double Blind, Double Dummy, Randomized, Controlled Trial
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
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
Acute Upper Respiratory Infection
China Academy of Chinese Medical Sciences
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