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

Study Overview
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Brief Summary
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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

Detailed Description
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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. 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 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. 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. 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. 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. Course of treatment：5 days

Official Title
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A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection: A Double Blind, Double Dummy, Randomized, Controlled Trial

Conditions
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Acute Upper Respiratory Infection

Intervention / Treatment
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* Drug: Jinyebaidu granule
* Drug: Fufangshuanghua granule
* Drug: Jinyebaidu granule placebo
* Drug: Fufangshuanghua granule placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Jinyebaidu granule, blunt, 10g / time, three times a day; Fufangshuanghua granule placebo, blunt, 6g / time, 4 times a day. | Drug: Jinyebaidu granule<br>* It is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb.<br>Drug: Fufangshuanghua granule placebo<br>* It is Fufangshuanghua granule placebo.<br>|
| Active Comparator: Control group<br>Fufangshuanghua granule, blunt, 6g / time, 4 times a day; Jinyebaidu granule placebo, blunt, 10g / times, three times a day. | Drug: Fufangshuanghua granule<br>* It is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata.<br>Drug: Jinyebaidu granule placebo<br>* It is Jinyebaidu granule placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to defervescence |  | defined as the time from the first dose of study medication to the time when the body temperature declined to lower than 37.3ºC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | change from baseline signs score at the fifth day | 
| Adverse events |  | 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 | 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 | Change from base line, on the fifth day | 
| Change of liver function | The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase | Change from base line, on the fifth day | 
| Change of renal function | The renal function includes creatinine,usea nitrogen | Change from base line, on the fifth day | 
| Incidence of ECG abnormalities |  | Change from base line, on the fifth day |