Phase IIaTrials of GanMaoKangNing Granules
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Flu recovery time
研究概览
简要总结
Randomized, double-blind, double- simulation, positive drug-and-Placebo-Controlled, multicenter, phase IIa clinical trials Study about GanMaoKangNing Granules in improving the symptoms of influenza.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent;
- •Male and female patients aged between 18 and 65 years old , there is no limit on the gender;
- •In line with the diagnostic criteria for pandemic influenza;
- •Duration less than 48 (Duration is defined as the time from onset to test drugs for the first time before, the onset time pointed out that now the axillary temperature 38.0 ℃, headache, muscle or joint pain, chills, fatigue, cough, sore throat and a stuffy nose eight any flu symptoms and signs in time);
- •The axillary temperature is 38.0 ℃ or higher;
- •Nose and throat swabs rapid virus antigen test result is positive.
排除标准
- •Severe influenza and of patients with complications of influenza.
- •With the following any severe risk factors:
- •A. With chronic respiratory diseases such as bronchial asthma, chronic obstructive pulmonary disease (copd), etc.
- •B. with chronic diseases of the cardiovascular system, such as congestive heart failure, high blood pressure.
- •C. with chronic metabolic and endocrine system diseases, such as poorly controlled diabetes (HbA1c 7.0% or higher).
- •D. with chronic kidney disease, chronic liver disease, blood system diseases, neurological and neuromuscular diseases (such as epilepsy, cognitive impairment, etc.).
- •E. A weakened immune system, such as long-term use of immunosuppressive agents, HIV infection or tumor.
- •F. Under the age of 19, long-term aspirin use. G. The obese (BMI BMI > 30).
- •With influenza complications, such as secondary bacterial pneumonia and other pathogenic bacteria and other viral pneumonia caused by pneumonia.
- •A history of peptic ulcer disease or gastrointestinal bleeding.
- •Into the group received within 48 h before flu antiviral treatment.
- •Into the group of 12 months before been vaccinated against the flu.
- •Into the group used within 2 weeks before the monoamine oxidase inhibitors.
- •Blood leukocyte count > 10.0 x 109 / L, neutrophils ratio > 80%, or the need for systemic antibiotic therapy.
- •For GanMaoKangNing Granules, Oseltamivir Phosphate Capsules, Acetaminophen Tablets, Dextromethorphan Hydrobromide Capsule, GanMaoKangNing Granules simulation agent or Oseltamivir Phosphate Capsules simulation agent composition of allergy, or allergic constitution.
- •Aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 1.5 x Upper Limit Normal (ULN)， Scr > Upper Limit Normal (ULN).
- •Doubt or does have a history of alcohol or drug abuse.
- •Pregnancy (defined as the pregnancy test positive), nursing mothers, or past in family planning.
- •For nearly three months participated in other clinical trials of patients.
- •Researchers think not appropriate to participate in this clinical subjects.
研究组 & 干预措施
Drugs for experimental group
GanMaoKangNing Granules， blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous Oseltamivir Phosphate Capsules,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.).
干预措施: GanMaoKangNing Granules (Drug)
Drugs for experimental group
GanMaoKangNing Granules， blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous Oseltamivir Phosphate Capsules,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.).
干预措施: Analogous Oseltamivir Phosphate Capsules (Drug)
Drugs for control group
Oseltamivir Phosphate Capsules ,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous GanMaoKangNing Granules, blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.).
干预措施: Oseltamivir Phosphate Capsules (Drug)
Drugs for control group
Oseltamivir Phosphate Capsules ,take oral,2 times a day,1 capsule each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.); Analogous GanMaoKangNing Granules, blunted by boiled water , 3 times a day, 2 bags each time, for a course of five days(During experiments, The condition of the subjects sicker or complications, Whether need to change or increase the treatment measures were determined by the researchers ,Stop using the medicine , completion of the relevant inspection and evaluation after medication,Quit the test,the case according to the invalid qualified cases statistics.).
干预措施: Analogous GanMaoKangNing Granules (Drug)
结局指标
主要结局
Flu recovery time
时间窗: six days
All the time needed for symptoms eased that from medication to fever and headache, muscle joint pain, chills, fatigue, cough, sore throat and a stuffy nose.
次要结局
- Single symptom remission rate(six days)
- The antifebrile effect(six days)