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Trial - TCTR20210714006


Column Value
Trial registration number TCTR20210714006
Full text link
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Jidapa Tragoonrungsea

Contact
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

janjy.t@gmail.com

Registration date
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-07-14

Recruitment status
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Age &gt,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
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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.

Number of arms
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Inclusion age min
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Thailand

Type of patients
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mild disease at enrollment

Severity scale
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1: Mild disease at enrollment

Total sample size
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

200

primary outcome
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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

Notes
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 3

Arms
Last imported at : Sept. 1, 2021, 11 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 242, "treatment_name": "Budesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]