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

Acute Upper Respiratory Infection Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Upper Respiratory Infection
• Infection
• Respiratory Tract Infections

• NCT number: NCT02539277
• Study type: Interventional
• Source: China Academy of Chinese Medical Sciences
• Contact: Junjie Jiang, doctor
• Phone: 86-18910206360
• Email: studentjiangjunjie@163.com
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2014
• Completion date: November 2015