- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03618407
Effect of Early Antiviral Therapy on Duration of Cough in Flu Patients
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Hubei
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Wuhan, Hubei, Kina, 430060
- Renmin Hospital of Wuhan University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HuKe
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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