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Phase IIaTrials of GanMaoKangNing Granules

2016年12月7日 更新者:Dalian Zhen-Ao Bio-Tech Co., Ltd.
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.

研究概览

研究类型

介入性

注册 (预期的)

96

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Beijing
      • Beijing Shi、Beijing、中国、100010
        • Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
        • 接触:
          • Jing Wang Jing Wang, Dr.
          • 电话号码:010-64011516
          • 邮箱lunlihui@163.com
        • 首席研究员:
          • QingQuan Liu Liu QingQuan, Dr.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.).
3 times a day, 2 bags each time.
2 times a day,1 capsule each time.
假比较器: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.).
2 times a day,1 capsule each time.
3 times a day, 2 bags each time.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Flu recovery time
大体时间: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.
six days

次要结果测量

结果测量
措施说明
大体时间
Single symptom remission rate
大体时间:six days

After the medication and three days later, The proportion of each individual symptoms of subjects which include of headache, muscle joint pain, chills, fatigue, cough, sore throat and a stuffy nose.

Symptoms defined as symptom scores dropped to 0 or 1 minute, and maintain for 24 h or more.

six days
The antifebrile effect
大体时间:six days

Antifebrile rate: After the medication and three days later, the percentage of Body temperature returned to normal subjects (the axillary temperature < 37.1 ℃, and maintain of 24 h or more time).

Medicine antifebrile time (h) : Medication for the first time to the axillary temperature < 37.1 ℃, and maintain of 24 h or more time.

six days

其他结果措施

结果测量
措施说明
大体时间
The conditions of drug utilization of the antipyretic and some cough medicine
大体时间:six days
Including acetaminophen tablets and capsule of dextromethorphan hydrobromide usage rate and dose.
six days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

初级完成 (预期的)

2019年7月1日

研究注册日期

首次提交

2016年11月30日

首先提交符合 QC 标准的

2016年12月7日

首次发布 (估计)

2016年12月12日

研究记录更新

最后更新发布 (估计)

2016年12月12日

上次提交的符合 QC 标准的更新

2016年12月7日

最后验证

2016年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • DalianZhen-Ao

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

GanMaoKangNing Granules的临床试验

3
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