A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection
NCT ID: NCT02539277
Last Updated: 2015-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
600 participants
INTERVENTIONAL
2014-12-31
2015-11-30
Brief Summary
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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
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group
Jinyebaidu granule, blunt, 10g / time, three times a day; Fufangshuanghua granule placebo, blunt, 6g / time, 4 times a day.
Jinyebaidu granule
It is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb.
Fufangshuanghua granule placebo
It is Fufangshuanghua granule placebo.
Control group
Fufangshuanghua granule, blunt, 6g / time, 4 times a day; Jinyebaidu granule placebo, blunt, 10g / times, three times a day.
Fufangshuanghua granule
It is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata.
Jinyebaidu granule placebo
It is Jinyebaidu granule placebo.
Interventions
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Jinyebaidu granule
It is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb.
Fufangshuanghua granule
It is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata.
Jinyebaidu granule placebo
It is Jinyebaidu granule placebo.
Fufangshuanghua granule placebo
It is Fufangshuanghua granule placebo.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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First Affiliated Hospital of Heilongjiang Chinese Medicine University
OTHER
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Beijing Hospital of Traditional Chinese Medicine
OTHER
Changchun University of Chinese Medicine
OTHER
Liaoning University of Traditional Chinese Medicine
OTHER
Shandong University of Traditional Chinese Medicine
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Junjie Jiang
assistant researcher
Principal Investigators
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Yanming Xie
Role: STUDY_CHAIR
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Locations
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Guang'anmen Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wensheng Qi
Role: primary
Other Identifiers
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20141107-3.0
Identifier Type: -
Identifier Source: org_study_id
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