JRCT ID: jRCTs041250213
Registered date:24/03/2026
Comparison of Olfactory Training in Olfactory Impaired Cases with Unknown Cause
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Idiopathic olfactory dysfunction |
| Date of first enrollment | 24/03/2026 |
| Target sample size | 60 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Study participants will be randomly assigned to either the soup food group or the olfactory training kit group at the time of enrollment. Participants in the soup food group will take the soup food once a day, either between meals or before meals. Participants in the olfactory training group will perform olfactory training twice a day. At a follow-up visit 12 weeks after the start of the study, if the study participants wish to continue their participation in the study, they will receive an additional 12-week supply of soup foods or olfactory training kits. |
Outcome(s)
| Primary Outcome | Average of odor recognition threshold in T&T olfactometry |
|---|---|
| Secondary Outcome | Number of correct answers to the card-based olfactory identification ability test (Open Essence), results of the daily smell questionnaire, questionnaires on diet and health status, olfactory stimulus/meal record card, and percentage of adverse event occurrence. |
Key inclusion & exclusion criteria
| Age minimum | >= 50age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1) Idiopathic olfactory dysfunction. 2) No apparent cause in medical history, such as common cold (including COVID-19), head trauma, or dementia. 3) No abnormal findings in the nasal sinuses on nasal fiberoptic or sinus CT. 4) No significant intracranial cerebral atrophy, cerebrovascular disease, or brain tumor on head MRI. 5) Average of odor recognition threshold in T&T olfactometry of 2.6 to 4.0 (moderately depressed) or 4.2 to 5.4 (severely depressed). 6) Age is 50 years or older. 7) Gender is unspecified. 8) Outpatients. 9) Independent in daily activities. 10) Written informed consent has been obtained from the patient, freely given after a sufficient explanation of the study and before participation. |
| Exclude criteria | 1) Patients with olfactory dysfunction for more than 3 years. 2) Patients who received olfactory stimulation therapy within 1 month prior to the start of the study. 3) Patients taking oral steroids, nasal steroids, zinc preparations, vitamin B12 preparations or Chinese herbal preparations. 4) Patients with a threshold value exceeding 8 dB in either the right or left tympanic nerve area in an electrical taste test. 5) Patients with a history of airway hypersensitivity disease such as poorly controlled asthma. 6) Patients with a history of food allergy, or with a positive test result for allergens that cause food allergy in allergy test View 39. 7) Patients suffering from or with a history of serious internal organ diseases. 8) Patients who are deemed inappropriate as study participants by the principal investigator or a physician in charge of the research. |
Related Information
| Primary Sponsor | Shiga Hideaki |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Hideaki Shiga |
| Address | 1-1,Daigaku,Uchinada,Kahoku,Ishikawa Ishikawa Japan 920-0293 |
| Telephone | +81-76-218-8147 |
| shigah@kanazawa-med.ac.jp | |
| Affiliation | Kanazawa Medical University |
| Scientific contact | |
| Name | Hideaki Shiga |
| Address | 1-1,Daigaku,Uchinada,Kahoku,Ishikawa Ishikawa Japan 920-0293 |
| Telephone | +81-76-218-8147 |
| shigah@kanazawa-med.ac.jp | |
| Affiliation | Kanazawa Medical University Hospital |