Clinical trial NCT02539277: A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection
Official title: A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection: A Double Blind, Double Dummy, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Upper Respiratory Infection
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Heilongjiang Chinese Medicine University
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Beijing Hospital of Traditional Chinese Medicine
name: Changchun University of Chinese Medicine
name: Liaoning University of Traditional Chinese Medicine
name: Shandong University of Traditional Chinese Medicine
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2015-09-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

Primary outcomes:
measure: The time to defervescence
timeFrame: 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 outcomes:
measure: Change of symptoms score
timeFrame: change from baseline symptoms score at the third day and at the fifth day
measure: Change of signs score
timeFrame: change from baseline signs score at the fifth day
measure: Adverse events
timeFrame: All the time in the study
measure: Change of routine blood test
timeFrame: Change from base line, on the fifth day
measure: Change of urine routine
timeFrame: Change from base line, on the fifth day
measure: Change of liver function
timeFrame: Change from base line, on the fifth day
measure: Change of renal function
timeFrame: Change from base line, on the fifth day
measure: Incidence of ECG abnormalities
timeFrame: Change from base line, on the fifth day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yanming Xie
role: STUDY_CHAIR
References: