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Phase IIaTrials of GanMaoKangNing Granules

7 décembre 2016 mis à jour par: 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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Anticipé)

96

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Beijing
      • Beijing Shi, Beijing, Chine, 100010
        • Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comparateur factice: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Flu recovery time
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Single symptom remission rate
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
The conditions of drug utilization of the antipyretic and some cough medicine
Délai: six days
Including acetaminophen tablets and capsule of dextromethorphan hydrobromide usage rate and dose.
six days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Achèvement primaire (Anticipé)

1 juillet 2019

Dates d'inscription aux études

Première soumission

30 novembre 2016

Première soumission répondant aux critères de contrôle qualité

7 décembre 2016

Première publication (Estimation)

12 décembre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

12 décembre 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 décembre 2016

Dernière vérification

1 novembre 2016

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • DalianZhen-Ao

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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