NCT03618407

Brief Summary

This study mainly focused on the effect of early antiviral treatment on the duration of cough in influenza patients.investigators conducted an early investigation of patients with positive influenza virus and asked whether patients used antiviral drugs in the early stages. According to the use of drugs, patients were divided into oral oseltamivir group, oral lotus phlegm group and other groups, and investigators will collected Inspection information and medication status,during the treatment period of patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 7, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

July 4, 2018

Last Update Submit

August 4, 2018

Conditions

Keywords

InfluenzaAntiviral TreatmentCoughOseltamivir capsuleLotus Clear Capsule

Outcome Measures

Primary Outcomes (1)

  • Cough duration

    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.

    6 months

Study Arms (3)

Oral oseltamivir group

Patients with influenza virus positive and early oral oseltamivir capsules

Oral Lotus Capsules group

Patients with positive influenza virus and early oral administration of lotus extract capsules

other group

Influenza virus positive patients who were not treated with oral lotus capsule or oseltamivir capsules early

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Flu patients who were diagnosed in our hospital from April 2018 to July 2019

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Saliva samples Sputum samples

MeSH Terms

Conditions

Influenza, HumanCough

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Respiratory and Critical Care Medicine II

Study Record Dates

First Submitted

July 4, 2018

First Posted

August 7, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

August 7, 2018

Record last verified: 2018-07

Locations