UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043543 |
|---|---|
| Receipt number | R000049725 |
| 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 |
| Date of disclosure of the study information | 2021/03/08 |
| Last modified on | 2021/09/06 09:10:36 |
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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
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
watanabe@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049725
