UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030585 |
|---|---|
| Receipt number | R000034925 |
| Scientific Title | Safety evaluation of an excessive consumption of a botanical extract-formulated food - Placebo control double blind parallel group comparison clinical trial - |
| Date of disclosure of the study information | 2018/01/05 |
| Last modified on | 2018/05/08 14:49:27 |
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Basic information
Public title
Safety evaluation of an excessive consumption of a botanical extract-formulated food
- Placebo control double blind parallel group comparison clinical trial -
Acronym
Safety evaluation of an excessive consumption of a botanical extract-formulated food
Scientific Title
Safety evaluation of an excessive consumption of a botanical extract-formulated food
- Placebo control double blind parallel group comparison clinical trial -
Scientific Title:Acronym
Safety evaluation of an excessive consumption of a botanical extract-formulated food
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive consumption of a botanical extract-formulated food for 4weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
< Safety>
Side effect incidence,Adverse event incidence, clinical examination items, physiological examination items
Key secondary outcomes
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
study food
5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 weeks.
Interventions/Control_2
Control food
5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 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. Healthy males and who females equal to or more than 20 years and less than 65 years of age
2.Subjects who can visit the medical institution at the scheduled visit date
3. Subjects who are able to understand the study and willing to provide written informed consent.
Key exclusion criteria
1. Subjects who systolic blood pressure is less than 90 mmHg.
2. Subjects who equal to or more than 30kg/m2of BMI.
3. Subjects who fall under diagnostic criteria of metabolic syndrome
4. Subjects who given surgery, or taken medication due to serious illness within a month
5. Subject who present heart, liver, kidney disorders.
6. Subjects who are taking drugs, foods for specified health use or functional foods which could affect this study. 7. Subjects who Females in pregnancy, lactation
and scheduled pregnancy period.
8. Subjects who with heavy use of alcohol, and heavy smoking.
9. Subject who have been felt ill by blood collection.
10. Subjects who donated 200 ml or more of blood within a month prior to the study
11.Subjects who with irregular eating habits.(Night shift worker)
12. Subjects who plan business trip or trip for 10 consecutive days or more.
13. Subjects who have allergy related to the study foods
14. Subjects who have chronic
diarrhea or chronic coprostasis
15. Subjects already participating in other clinical trials, or
planning to participate during this examination period
16. Subjects who can not agree with preliminary explanation
17. Subjects who are deemed to be unsuitable by the investigator.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Fukuhara |
Organization
Fukuhara Clinic
Division name
Hospital director
Zip code
Address
3-1-15 Shimamatsuhigashi-machi Eniwa, Hokkaido, Japan
TEL
0123-36-8029
i-feniwa@gray.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | endoh yoshiki |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
Address
452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
y-endoh@ndrcenter.co.jp
Sponsor or person
Institute
Maruzen Pharmaceuticals Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals 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
Address
Tel
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
| 2018 | Year | 01 | Month | 05 | 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
| 2017 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 27 | Day |
Last modified on
| 2018 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034925
