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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

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 - 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043543
Enrollment
60
Registered
2021-03-08
Start date
2021-03-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

Interventions

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

Sponsors

Healthcare Systems Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document. 2.Healthy Japanese who are 20 years old or more and under 65 years old. 3.Persons who have nasal or eye discomfort due to pollen or other causes but are not receiving otolaryngology consultation or medication.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
QOL Questionnaire (Using the japan rhinoconjunctivitis quality of life questionnaire, JACQLQ ver.1)

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactEriko Watanabe

Healthcare Systems Co., Ltd. Research and Development Department

watanabe@hc-sys.jp03-6809-2722

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026