UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030307 |
|---|---|
| Receipt number | R000034614 |
| Scientific Title | A study to evaluate the safety of excessive ingestion of licorice flavonoid oil for healthy adults. |
| Date of disclosure of the study information | 2017/12/18 |
| Last modified on | 2018/05/22 09:19:49 |
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Basic information
Public title
A study to evaluate the safety of excessive ingestion of licorice flavonoid oil for healthy adults.
Acronym
A study to evaluate the safety of excessive ingestion of licorice flavonoid oil for healthy adults.
Scientific Title
A study to evaluate the safety of excessive ingestion of licorice flavonoid oil for healthy adults.
Scientific Title:Acronym
A study to evaluate the safety of excessive ingestion of licorice flavonoid oil for healthy adults.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive ingestion of licorice flavonoid oil containing food for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematology test
Blood biochemistry test
Urinalysis
Blood pressure/pulsation
Body weight
Doctor's questions
Adverse event
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
Ingestion of licorice flavonoid oil containing food (5 soft gels 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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females aged 20-69 years.
Key exclusion criteria
(1)With allergy to the study foods.
(2)Subjects who has a disease under treatment.
(3)Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, heart disease or cancer).
(4)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(5)Subjects who constantly take in supplement richly containing licorice glabra polyphenol or licorice flavonoid oil.
(6)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination at the screening.
(7)Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work or going overseas.
(8)Subjects who have participated in other clinical study within the last one month prior to the current study.
(9)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(10)Subjects who are judged as unsuitable by doctor for other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Morikawa |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition Solutions Vehicle, Supplemental Nutrition Devision
Zip code
Address
2-3-18, Nakanoshima, Kita-ku, Osaka
TEL
050-3133-7673
Hideyuki.Morikawa@kaneka.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saki Fukuchi |
Organization
TTC CO., LTD.
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2 Ebisunishi, Shibuya-ku, Tokyo JAPAN
TEL
03-5459-5329
Homepage URL
s.fukuchi@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
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 | 12 | Month | 18 | 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 | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 18 | 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 | 08 | Day |
Last modified on
| 2018 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034614
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
