Examination of the effect of nasal irrigation in patients with cedar pollinosis

JRCT ID: jRCTs052220146

Registered date:05/01/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: cedar pollinosis
• Date of first enrollment: 03/02/2023
• Target sample size: 45
• Study type: Interventional

Intervention(s)

Groups A and B only
Rinse the left and right nasal passages twice a day with 50 mL of normal saline or a special cleaning solution

Outcome(s)

• Primary Outcome: JRQLQ (Nasal symptom questionnaire)

Secondary Outcome

1)Blood allergy test (total IgE level, antigen-specific IgE level)
2)Background of Research Participants
3)Nasal findings: edema of the nasal mucosa, color of the nasal mucosa, the degree of dryness of the nasal mucosa
4)Intranasal flora
5) Nasal discharge collection: determination of cedar-specific IgE antibodies, albumin, and short-chain fatty acids in nasal secretions, Proteins, peptide mixtures, metabolites of glycolytic systems, amino acids, organic acids, etc.
6)Nasal NO value
7)Comprehensive analysis of genes in nasal mucosal epithelial cells

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Faculty members working at the University of Fukui Matsuoka Campus or students enrolled in the University of Fukui Faculty of Medicine
2)A person who can obtain written consent from the person
3)Those who have a positive antigen-specific IgE antibody test at the time of pre-registration test with cedar pollen
4)Those who develop allergic symptoms every year during the cedar pollen allergy season.
5)Those who comply with the compliance rules while participating in this research, undergo medical examinations and examinations specified in this research plan, and are able to report symptoms, etc.

Exclude criteria

1)People with a nasal irrigation rate of 80% or less
2)In the case of using therapeutic drugs for cedar pollinosis, those who started use, discontinued use, or changed the dosage during the period from 3 days prior to the start of the study to the end of the study.
3) Those who did not take the two tests after registration within the period
4)Persons who are judged by the investigator to be inappropriate for enrollment in this research

Related Information

• Primary Sponsor: Masafumi Sakashita
• Source(s) of Monetary Support: Kobayashi Pharmaceutical Co., Ltd.