- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03618407
Effect of Early Antiviral Therapy on Duration of Cough in Flu Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Cough is a common symptom of respiratory diseases and helps to clear respiratory secretions and harmful factors, but frequent severe coughing has a serious impact on the patient's work, life and social activities. Upper respiratory tract viral infection is a common cause of coughing. Many patients have a long duration of cough after suffering from flu. Cough can last for several weeks, and most often have irritating dry cough or a small amount of white mucus sputum. This type of cough is also often referred to as "subacute cough" or "post-infection cough." The mechanisms that cause this cough have not been fully elucidated, and the effect of conventional treatment is not good, and chest imaging has no obvious abnormalities. The use of large amounts of antibiotics is ineffective or ineffective. Antihistamine H1 receptor antagonists and central antitussives are often only effective or ineffective in the short term. The effects of various bronchodilators and even hormone drugs are not clear. Due to the poor efficacy of multiple treatments, patients are repeatedly subjected to various tests, which not only increases the pain but also aggravates the economic burden.
Therefore, it is necessary to further clarify the causes and treatment measures of post-influenza cough patients.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Hubei
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Wuhan, Hubei, Kina, 430060
- Renmin Hospital of Wuhan University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
For patients with flu-free flu, cough for at least one week.
- In line with the flu etiological diagnostic criteria: According to the guidelines set by the National Health and Health Committee, the diagnosis is based on etiological screening methods or confirmed methods; ages 18 to 70 years.
- There are no influenza complications such as acute lower respiratory tract infection, tonsillitis, sinusitis, otitis media, myocarditis, etc.
- It is usually healthy and there are no chronic underlying diseases such as hypertension and diabetes.
- Treating with cough as the main symptom, the cough lasts for at least one week and the chest radiograph is normal.
- Signed informed consent.
Exclusion Criteria:
- Suspected flu patients who have not received the flu etiology test;
- There is a clear comorbid disease (combined with other sites of acute bacterial or viral infections);
- There is a clear cough caused by other reasons;
- With severe liver and kidney dysfunction;
- Pregnant women.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Oral oseltamivir group
Patients with influenza virus positive and early oral oseltamivir capsules
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Oral Lotus Capsules group
Patients with positive influenza virus and early oral administration of lotus extract capsules
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other group
Influenza virus positive patients who were not treated with oral lotus capsule or oseltamivir capsules early
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cough duration
Tidsramme: 6 months
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Investigators will follow up every other week for follow-up calls or outpatients to ask about cough and medication, until the patient stops coughing, cough lasts from 1 day to 12 weeks, and cough time is greater than 12 weeks.
Investigators should seriously exclude cough caused by other factors.
No other factors are still included in the study, and the maximum time is no more than 6 months.
If there are other factors causing cough, it will not be included in the study.
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6 months
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HuKe
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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