NCT02539277

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Upper Respiratory Infection

Interventions

Type	Name	Description
DRUG	Jinyebaidu granule	It is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb.
DRUG	Fufangshuanghua granule	It is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata.
DRUG	Jinyebaidu granule placebo	It is Jinyebaidu granule placebo.
DRUG	Fufangshuanghua granule placebo	It is Fufangshuanghua granule placebo.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-09-03
• Last updated: 2015-09-03

Locations

1 site across 1 country: China