UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028987 |
|---|---|
| Receipt number | R000033166 |
| Scientific Title | Safety evaluation studies of high dose intake of capsules including herb extract |
| Date of disclosure of the study information | 2017/09/07 |
| Last modified on | 2018/02/28 19:34:57 |
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Basic information
Public title
Safety evaluation studies of high dose intake of capsules including herb extract
Acronym
Safety evaluation studies of high dose intake of capsules including herb extract
Scientific Title
Safety evaluation studies of high dose intake of capsules including herb extract
Scientific Title:Acronym
Safety evaluation studies of high dose intake of capsules including herb extract
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 ingestion of foods containing herb extract,
5-fold quantity of recommended daily intake.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/ body mass index
Doctor's questions
Adverse event
Evaluate at points of 2 week and 4 week of ingestion and 2 weeks after the end of ingestion 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
Oral ingestion of the test product 10 grains per day, 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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult males and females from 20 to 64 years of age
Key exclusion criteria
(1) Subjects who routinely use health food richly containing herb extract
(2) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(3) Subjects having possibilities for emerging allergy related to the study
(4) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required
(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 have participated in other clinical studies
(7) Subjects who intend to become pregnant or lactating
(8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(9) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohide Sakaguchi |
Organization
Nippon Shinyaku Co.,Ltd.
Division name
Food Development Labs.
Zip code
Address
14,Nishinosho-monguchi-cho,Kisshoin, Minami-ku,Kyoto
TEL
075-321-9027
h.sakaguchi@po.nippon-shinyaku.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiko Wasaki |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2, Ebisunishi, shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
k.wasaki@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Shinyaku 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
| 2017 | 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
| 2017 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 08 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2018 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033166
