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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000044259 |
Receipt No. | R000050552 |
Scientific Title | Verification of the effects of foods containing natural products on cold symptoms. |
Date of disclosure of the study information | 2022/06/20 |
Last modified on | 2021/05/19 |
Basic information | ||
Public title | Verification of the effects of foods containing natural products on cold symptoms. | |
Acronym | Verification of the effects of foods containing natural products on cold symptoms. | |
Scientific Title | Verification of the effects of foods containing natural products on cold symptoms. | |
Scientific Title:Acronym | Verification of the effects of foods containing natural products on cold symptoms. | |
Region |
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Condition | ||
Condition | healthy adults | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Examine the effects of foods containing natural products on cold symptoms |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Visual Analogue Scale
Number of days with illness |
Key secondary outcomes | OSA sleep inventory MA version
Chalder Fatigue Scale |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | No need to know |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Foods containing natural products 2 tablets / day | |
Interventions/Control_2 | Placebo Foods 2 tablets / day | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) persons who is generally judged
as healthy (2) Persons who can give voluntary Written consent to participate In the present trial (3) Persons Those who have a feeling of physical and mental fatigue |
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Key exclusion criteria | (1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study
(2) persons who have changed their habitats to take supplements within past 4 weeks. (3) Persons who work in night shift or in day and night shift (4) persons who have been treated their illness or prevention in a clinic at their informed consent (5) persons with their medical histories as follows: serious diseases of sugar metabolism,lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6) persons with the medical histories of alcoholism or drug dependence (7) persons who might be developed allergic reaction to foods. (8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10)persons who will not be judged suitable to the participants by the investigator. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kindai University | ||||||
Division name | Faculty of humanity-oriented science and engineering | ||||||
Zip code | 820-8555 | ||||||
Address | 11-6, Kayanomori, Iizuka-shi, Fukuoka | ||||||
TEL | 0948-22-5655 | ||||||
ohnuki@fuk.kindai.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | User Life Science Co., Ltd. | ||||||
Division name | The research and development part | ||||||
Zip code | 820-0115 | ||||||
Address | 372-3, Niho, Izuka, Fukuoka, JAPAN | ||||||
TEL | 0948-82-3123 | ||||||
Homepage URL | |||||||
userlifesciense@gmail.com |
Sponsor | |
Institute | User Life Science Co., Ltd. |
Institute | |
Department |
Funding Source | |
Organization | FS Lab Co., Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Faculty of Agriculture, Kyushu University |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Kinki University Faculty of Industrial Science and Technology Ethics Committee |
Address | 11-6 Kayanomori, Iizuka City, Fukuoka Prefecture 820-8555 |
Tel | 0948-22-5655 |
ohnuki@fuk.kindai.ac.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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 36 |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050552 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |