UMIN-CTR Clinical Trial

Basic information
Public title	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
Acronym	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
Scientific Title	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
Scientific Title:Acronym	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
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine the effects of capsules containing dried powder of ecklonia stolonifera from Nishinoshimachou on nasal and eye discomfort when taken continuously for four weeks by Japanese men and women aged 20 to 64 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL Questionnaire (Using the japan rhinoconjunctivitis quality of life questionnaire, JACQLQ ver.1)
Key secondary outcomes	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)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingest 250 mg of dextrin (1 tablet) daily for 4 weeks
Interventions/Control_2	Ingest 340 mg of capsules containing dried powdered ecklonia tolonifera from Nishinoshimachou (1 tablet) daily for 4 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key 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.
Key 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.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Eriko Middle name Last name Watanabe
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Email	watanabe@hc-sys.jp

Public contact
Name of contact person	1st name Eriko Middle name Last name Watanabe
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Homepage URL
Email	watanabe@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd
Institute
Department

Funding Source
Organization	TAKAKI Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Nishinoshimachou

IRB Contact (For public release)
Organization	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel	03-6809-2722
Email	soumu@hc-sys.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 03 Month 07 Day
Date of IRB	2021 Year 03 Month 07 Day
Anticipated trial start date	2021 Year 03 Month 08 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 07 Day
Last modified on	2021 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049725