- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02989012
Phase IIaTrials of GanMaoKangNing Granules
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
Beijing
-
Beijing Shi, Beijing, China, 100010
- Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
-
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Comparador Falso: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Flu recovery time
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Single symptom remission rate
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The conditions of drug utilization of the antipyretic and some cough medicine
Prazo: six days
|
Including acetaminophen tablets and capsule of dextromethorphan hydrobromide usage rate and dose.
|
six days
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Conclusão Primária (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DalianZhen-Ao
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