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

China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Acute Upper Respiratory Infection

Treatments: Drug: Fufangshuanghua granule placebo; Drug: Fufangshuanghua granule; Drug: Jinyebaidu granule; Drug: Jinyebaidu granule placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02539277

20141107-3.0

Details and patient eligibility

About

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

Full 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

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

Treatment group

Experimental group

Description:

Jinyebaidu granule, blunt, 10g / time, three times a day; Fufangshuanghua granule placebo, blunt, 6g / time, 4 times a day.

Treatment:

Drug: Fufangshuanghua granule placebo

Drug: Jinyebaidu granule

Control group

Active Comparator group

Description:

Fufangshuanghua granule, blunt, 6g / time, 4 times a day; Jinyebaidu granule placebo, blunt, 10g / times, three times a day.

Treatment:

Drug: Jinyebaidu granule placebo

Drug: Fufangshuanghua granule