NIPH Clinical Trials Search

Human intervention trial on the effect of long-term ingestion of dry powdered ecklonia stolonifera from Nishinoshima-chou on the reduction of nasal and eye discomfort

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy Adults
Date of first enrollment	2021/03/08
Target sample size	60
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Ingest 250 mg of dextrin (1 tablet) daily for 4 weeks Ingest 340 mg of capsules containing dried powdered ecklonia tolonifera from Nishinoshimachou (1 tablet) daily for 4 weeks

Outcome(s)

Primary Outcome	QOL Questionnaire (Using the japan rhinoconjunctivitis quality of life questionnaire, JACQLQ ver.1)
Secondary Outcome	Evaluation of subjective nasal and eye symptoms (by recording in daily diary) Blood tests (6 specific IgE items, non-specific IgE, CRP) s-IgA in saliva (concentration, secretion rate)

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	65years-old
Gender	Male and Female
Include criteria
Exclude criteria	1.Persons who have chronic illness, receiving medication, have a serious disease history (diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease, etc.) 2.Persons who have allergy to the test food (ecklonia stolonifera), shrimp and crab. 3.Persons who regularly take test food (ecklonia stolonifera). 4.Persons who regularly take seaweed, foods containing seaweed or supplements. 5.Persons who are seeing or planning to see an otorhinolaryngologist. 6.Persons who have been diagnosed with acute rhinitis, sinusitis, or hypertrophic rhinitis. 7.Persons who have been diagnosed with bronchial asthma. 8.Persons who have severe anemia, alcoholism, or other mental disorders. 9.Persons who have a smoking habit. 10.Persons who regularly use medicines, specified health foods, or health foods that may affect nasal or eye discomfort. 11.Persons who may change their lifestyle during the study period (e.g., working at night, traveling for long periods of time). 12.Persons who plan to take new health foods or supplements during the study period. 13.Persons who have participated in other studies during the month prior to the start of the study, or persons who plan to participate in other studies after consenting to this study. 14.Persons who have been judged ineligible by the study supervising physician or principal investigator. 15.Persons who are breast-feeding, pregnant, or who plan or wish to become pregnant during the study period.