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| Column | Value |
|---|---|
| Trial registration number | NCT05421195 |
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Full text link
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
hongmengyush@163.com |
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Registration date
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
2022-06-16 |
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Recruitment status
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : June 23, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: 1. previous diagnosis of covid-19 infection; 2. olfactory function was normal in the past, and the olfactory function decreased due to covid-19 infection, which has occurred more than 2 weeks; 3. olfactory function test score: tdi ≤ 30; 4.18 ≤ age ≤ 55 years old; 5.good overall physical condition, without other diseases that may affect the test; 6. no active infection, such as uncontrolled pneumonia; 7. women with reproductive potential and sexually active men agree to use acceptable and effective contraceptive methods. |
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Exclusion criteria
Last imported at : June 23, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
1. participants who refuse to sign informed consent; 2. participants who have other diseases that affect the result, such as trauma, benign and malignant tumors of nasal cavity and paranasal sinuses, intracranial benign and malignant tumors, etc; 3. participants with uncontrolled concurrent diseases that the researcher believes will interfere with the treatment; 4. participants who has contraindications to oral corticosteroids, such as serious gastric and duodenal ulcer, diabetes, glaucoma, etc; 5. participants who have serious neurological or mental diseases, including dementia and seizures; 6.participants who have oral corticosteroids history within 2 weeks, or who have recently taken a large amount of oral corticosteroids and are not suitable after the evaluation of the researcher; 7. participants who have used corticosteroids therapy during the treatment of covid-19 and olfactory function didn't recover; 8. pregnant or lactating women; 9. persons without personal freedom and independent civil capacity; 10. participants who have been enrolled in other intervention clinical trials; 11. participants who with autoimmune diseases; 12. participants who has any situation that may hinder the compliance of the protocol study or the safety during the study; 13. other situations that the investigators think are not suitable for the trial. |
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Number of arms
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Eye & ENT Hospital of Fudan University |
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Inclusion age min
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
55 |
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Countries
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
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Severity scale
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
124 |
|
primary outcome
Last imported at : June 23, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
Olfactory function test result：the sum of the scores of odor threshold (T), odor discrimination (D), and odor identification (I) is TDI. |
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Notes
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
Not reported |
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Arms
Last imported at : June 18, 2022, 7 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 919, "treatment_name": "Olfactory training", "treatment_type": "Olfactory training", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "+ olfactory training", "treatment_id": 329, "treatment_name": "Corticosteroid", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}] |