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Corticosteroid Nasal Irrigation as Early Treatment of Olfactory Dysfunction in COVID-19: A prospective randomized controlled trial

Corticosteroid Nasal Irrigation as Early Treatment of Olfactory Dysfunction in COVID-19: A prospective randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210714006
Enrollment
200
Registered
2021-07-14
Start date
2021-07-12
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Patients will received 1 mg budesonide (Pulmicort Respules) and 4.5 g sodium chloride powder (Rama salt) to mix with 500 ml boiled water. Nasal irrigation will be performed with 125-mL each nostril, 2
Budesonide group,Saline group ,No irrigation group

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Nasal 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.

Countries

Thailand

Contacts

Public ContactJidapa Tragoonrungsea

Faculty of Medicine Ramathibodi Hospital, Mahidol University

janjy.t@gmail.com0841134459

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026