Treatment of olfactory dysfunction by Topical Application of Basic Fibroblast Growth Factor

JRCT ID: jRCTs061240046

Registered date:14/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: olfactory disorder
• Date of first enrollment: 14/08/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Local administration of bFGF-impregnated gelatin hydrogel to the olfactory cleft on the first day of treatment

Outcome(s)

• Primary Outcome: Improvements in average cognitive thresholds three months after treatment

Secondary Outcome

Mean cognitive threshold and change in standard olfaction test after 1 month of treatment
Percentage of "cured" and "mildly cured" after 3 months of treatment
Mean cognitive threshold and amount of change after 3 months of treatment by severity
Amount of change in open essences 1 month and 3 months after onset
Daily Smell Questionnaire and Olfactory Disorder VAS scores at 1 month and 3 months after onset

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

Patients with olfactory disorder treatment started between 4 weeks and 1 year after onset of olfactory disorder can be evaluated three months after treatment
Patients with olfactory impairment with an average cognitive threshold of 2.6 or higher on the T&T olfactometer
age of at least 20 to under 65 years old
Written informed consent

Exclude criteria

When the patient cannot come to the hospital
Cases with confirmed central olfactory disorders or other nasal sinus diseases (such as olfactory neuroblastoma)
Cases judged inappropriate by the attending physician
Patients with a history of allergy to gelatin or trafermin
Patients who cannot take Tokisyakuyakusan

Related Information

• Primary Sponsor: Hato Naohito