- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02989012
Phase IIaTrials of GanMaoKangNing Granules
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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Beijing
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Beijing Shi, Beijing, Kiina, 100010
- Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
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Ottaa yhteyttä:
- Jing Wang Jing Wang, Dr.
- Puhelinnumero: 010-64011516
- Sähköposti: lunlihui@163.com
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Päätutkija:
- QingQuan Liu Liu QingQuan, Dr.
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: 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.
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Huijausvertailija: 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.).
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2 times a day,1 capsule each time.
3 times a day, 2 bags each time.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Flu recovery time
Aikaikkuna: six days
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Single symptom remission rate
Aikaikkuna: 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
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The antifebrile effect
Aikaikkuna: six days
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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
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
The conditions of drug utilization of the antipyretic and some cough medicine
Aikaikkuna: six days
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Including acetaminophen tablets and capsule of dextromethorphan hydrobromide usage rate and dose.
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six days
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Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Ensisijainen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- DalianZhen-Ao
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