Corticosteroid Nasal Irrigation as Early Treatment of Olfactory Dysfunction in COVID-19: A prospective randomized controlled trial
Phase 3
Recruiting
- Conditions
- The eligible COVID-19 patients who admit at Ramathibodi Hospitel, Ramathibodi Hospital and Ramathibodi Chakri Naruebodindra Hospital with new onset smell loss who capable to perform nasal irrigation themselves.COVID-19, Anosmia, Hyposmia, Budesonide
- Registration Number
- TCTR20210714006
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
1.Age >18 years
2.Confirmed COVID-19 test positive with new onset of smell dysfunction
3.Patients who capable to perform nasal irrigation themselves
Exclusion Criteria
1.Chronic use of nasal or systemic corticosteroids
2.History of smell loss before COVID-19 era
3.Previous history of rhinological diseases such as chronic rhinosinustis, nasal tumor, anatomical abnormalities of the nose
4.Pregnancy
5.The patients who refuse to enroll the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Smell sensation at baseline, post-irrigation 1 week, 2 weeks, 3 weeks, 4 weeks and 6 weeks. VAS score -VAS will be graded by patients which zero is completely normal smell sensation and ten is total loss of smell. ,Smell perception of specific odors (fish sauce, orange, coffee and jasmine ) at baseline, post-irrigation 1 week, 2 weeks, 3 weeks, 4 weeks and 6 weeks. Total Visual analog scale (VAS score) of smell perception of specific odors including 4 well-recognized odors for the Thai population. Specific odors include fish sauce, orange, coffee and jasmine ,Time to correct identification more than75% of odors and number of odors identification at each follow-up among each group baseline, post-irrigation 1 week, 2 weeks, 3 weeks, 4weeks and 6 weeks. Identification of 4 well-recognized odors for the Thai population will be assessed to evaluate time to recovery and number of odors identification at each follow-up among each group
- Secondary Outcome Measures
Name Time Method asal symptoms at baseline, post-irrigation 1 week, 2 week, 3 week, 4 weeks and 6 week. Visual analog scale (VAS score) of nasal symptoms ,Side effects of Budesonide nasal irrigation at postoperative 1 week and 2 weeks. Pharyngeal and nasal burning/dryness will be evaluated.