Diagnostic Self Evaluation Clinical Trial
Official title:
The Objective Assessment and Characteristics of Dry Nose From Clinical Perspective
NCT number | NCT05401344 |
Other study ID # | V 1.0 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 11, 2018 |
Est. completion date | October 31, 2021 |
Verified date | December 2018 |
Source | Beijing Tongren Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In the present study, we propose objective diagnostic criteria for dry nose (DN) and investigate its characteristics. Questionnaires were completed by each participant during recruitment to record demographic data. DN test strips were used to evaluate the severity of DN at five time points and allergic status was assessed based on serum sIgE levels. Nasal secretions were collected and vasomotor rhinitis was diagnosed using the cold dry air test. The diagnosis of allergic rhinitis (AR) was based on the criteria of the Allergic Rhinitis and its Impact on Asthma consensus statement. Data are expressed as median and interquartile range, unless otherwise specified. Statistical significance was set at P < 0.05. The reference range (RR) of the 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles were determined for each test strip length at each time point. This study aimed to investigate the characteristics of and propose objective diagnostic criteria for DN.
Status | Completed |
Enrollment | 120 |
Est. completion date | October 31, 2021 |
Est. primary completion date | July 24, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 23 Years to 73 Years |
Eligibility | Inclusion Criteria: - Clinical diagnosis of dry nose patients. Exclusion Criteria: - chronic rhinosinusitis and/or nasal polyposis, allergic fungal rhinosinusitis, immunological disease, tumor patients, pregnant women. |
Country | Name | City | State |
---|---|---|---|
China | Yifan Meng | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tongren Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The length of the test strip. | We propose that the diagnostic criterion for DN is a strip length less than 17.0 mm at 5 min. | 5 minutes |
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