A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection: A Double Blind, Double Dummy, Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The time to defervescence
研究概览
简要总结
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
详细描述
- 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.
- 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
- 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.
- 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.
- 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.
- Dose regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
Treatment group
Jinyebaidu granule, blunt, 10g / time, three times a day; Fufangshuanghua granule placebo, blunt, 6g / time, 4 times a day.
干预措施: Jinyebaidu granule (Drug)
Treatment group
Jinyebaidu granule, blunt, 10g / time, three times a day; Fufangshuanghua granule placebo, blunt, 6g / time, 4 times a day.
干预措施: Fufangshuanghua granule placebo (Drug)
Control group
Fufangshuanghua granule, blunt, 6g / time, 4 times a day; Jinyebaidu granule placebo, blunt, 10g / times, three times a day.
干预措施: Fufangshuanghua granule (Drug)
Control group
Fufangshuanghua granule, blunt, 6g / time, 4 times a day; Jinyebaidu granule placebo, blunt, 10g / times, three times a day.
干预措施: Jinyebaidu granule placebo (Drug)
结局指标
主要结局
The time to defervescence
时间窗: defined as the time from the first dose of study medication to the time when the body temperature declined to lower than 37.3ºC
次要结局
- Change of liver function(Change from base line, on the fifth day)
- Change of urine routine(Change from base line, on the fifth day)
- Change of renal function(Change from base line, on the fifth day)
- Change of symptoms score(change from baseline symptoms score at the third day and at the fifth day)
- Change of signs score(change from baseline signs score at the fifth day)
- Adverse events(All the time in the study)
- Change of routine blood test(Change from base line, on the fifth day)
- Incidence of ECG abnormalities(Change from base line, on the fifth day)
研究者
Junjie Jiang
assistant researcher
China Academy of Chinese Medical Sciences