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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030591
Receipt No. R000034935
Scientific Title Safety evaluation of an excessive consumption of a food containing botanical extract - 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 food containing botanical extract
- Placebo control double blind parallel group comparison clinical trial -
Acronym Safety evaluation of an excessive consumption of a food containing botanical extract
Scientific Title Safety evaluation of an excessive consumption of a food containing botanical extract
- Placebo control double blind parallel group comparison clinical trial -
Scientific Title:Acronym Safety evaluation of an excessive consumption of a food containing botanical extract
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 food containing botanical extract 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 females who 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 25kg/m of BMI
3. Subjects who given surgery, or taken medication due to serious illness within a month
4. Subject who present heart, liver, kidney disorders
5. Subjects who are taking drugs, foods for specified health use or functional foods which could affect this study
6. Subjects who Females in pregnancy, lactation and scheduled pregnancy period
7 Subjects who with heavy use of alcohol, and heavy smoking
8. Subject who have been felt ill by blood collection
9. Subjects who donated 200 ml or more of blood within a month prior to the study
10 Subjects who with irregular eating habits(Night shift worker)
11. Subjects who plan business trip or trip for 10 consecutive days or more
12. Subjects who have allergy related to the test foods
13. Subjects who have chronic diarrhea or chronic coprostasis
14.Subjects who already participating in other clinical trials, or planning to participate during this examination period
15. Subjects who can not agree with prliminary explanation
16. 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 Miura Hirona
Organization Higashi shinjuku Clinic
Division name Hospital director
Zip code
Address 1-11-3, Okubo Shinjuku-ku, Tokyo
TEL 03-6233-8583
Email koike@meiseikai-cl.com

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 29 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=R000034935

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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