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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030585
Receipt No. 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

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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
Email 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
Email y-endoh@ndrcenter.co.jp

Sponsor
Institute Maruzen Pharmaceuticals Co., Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034925

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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