UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052066 |
|---|---|
| Receipt number | R000059426 |
| Scientific Title | Safety confirmation studies of excessive intake of rush extract in healthy adult men and women. |
| Date of disclosure of the study information | 2023/09/07 |
| Last modified on | 2024/02/20 18:51:25 |
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Basic information
Public title
Safety evaluation
Acronym
Safety evaluation
Scientific Title
Safety confirmation studies of excessive intake of rush extract in healthy adult men and women.
Scientific Title:Acronym
Safety confirmation studies of excessive intake of rush extract in healthy adult men and women.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive intake of dehydroeffusol-containing foods 5 times as much as the recommended daily intake for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Laboratory test (Hematologic test, Blood biochemistry test, Urine analysis), Physical examination (Blood pressure/pulsation, Weight/body mass index) and Adverse event
Evaluate at points of 2 weeks and 4 weeks of intake and 2 weeks after the end of intake period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
5 grains of the test product daily oral intake for 4 weeks.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adult men and women between the ages of 18 and 64
(2) Subject who fully understand the purpose and content of the study and agree to participate in the research of their own volition
Key exclusion criteria
(1) Subjects who constantly use health food richly containing involvement ingredient.
(2) Subjects who are judged as unsuitable for this study by the principal investigator based on the results of clinical examination or cardiopulmonary abnormality.
(3) Subjects who have possibilities for emerging allergy related to the study.
(4) Subjects having a disease requiring regular medication or a history of serious
(5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(6) Subjects who are engaged in day / night shift work, midnight work, or irregular life habits.
(7) Subjects who have participated in other clinical studies
(8) Subjects who intend to become pregnant or lactating
(9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10) Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Ohkawara |
Organization
Satoen Co., LTD.
Division name
None
Zip code
421-1392
Address
1057 Ohhara, Aoi-ku, Shizuoka, Japan
TEL
054-270-1336
okawara358@satoen.co.jp
Public contact
Name of contact person
| 1st name | Rio |
| Middle name | |
| Last name | Fujiwara |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning Section 1
Zip code
162-0821
Address
1-8 Tsukudocho, Shinjuku-ku, Tokyo Kagurazaka AK Building 7F
TEL
070-7079-8488
Homepage URL
fujiwara.rio605@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Satoen Co., LTD.
HAGIHARA & CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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
| 2023 | Year | 09 | Month | 07 | 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
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
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 31 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059426
