UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012820 |
|---|---|
| Receipt number | R000014938 |
| Scientific Title | A randomized control trial of UNAHATAKE herb extract intake on anti- glycation effect and improvement in skin. |
| Date of disclosure of the study information | 2014/01/14 |
| Last modified on | 2016/05/02 22:35:50 |
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Basic information
Public title
A randomized control trial of UNAHATAKE herb extract intake on anti- glycation effect and improvement in skin.
Acronym
Anti-glycation effect of "herb extract" on human skin.
Scientific Title
A randomized control trial of UNAHATAKE herb extract intake on anti- glycation effect and improvement in skin.
Scientific Title:Acronym
Anti-glycation effect of "herb extract" on human skin.
Region
| Japan |
Condition
Condition
Post-menopausal middle-aged female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the anti-glyaction effect ond skin inmrovement by 12-week oral treatment of UNAHANA herb extract.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin elasticity, skin CML, skin AGEs accumulation, skin color, skin image analysis by VISIA, fasting plasma glucose, insulin, CML, 3-deoxyglucosone, pentosidine, questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Test group
Oral intake of capsules with 300mg UNAHATAKE herb extract after breakfast for 12 weeks
Interventions/Control_2
Control group
Oral intake of capsules without UNAHATAKE herb extract after breakfast for 12 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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Post-menopause healthy Japanese women ages 45 or more and less than 65 years old
Key exclusion criteria
1) Persons less than 2 years after menopause
2) Smoking persons
3) Users of anti-glycation materials
4) Users of medicines or supplements affecting blood glucose
5) Persons with severe dysfunction of liver, kidney or heart
6) Persons with food allergy or allergic dermatitis
7) Persons who received gastrointestinal surgery
8) Persons with high BMI more than 30
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Yonei |
Organization
Graduate School of Life and Medical Sciences, Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
Address
1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Naito |
Organization
A-kit Corporation
Division name
Life and Medical Sciences Inspection center
Zip code
Address
4-3-2 sawaragi-nishi,Ibaraki City,Osaka
TEL
072-646-7761
Homepage URL
naito@a-kit.co.jp
Sponsor or person
Institute
Anti-Aging Medical Research Center, Graduate School of Life and Medical Sciences, Doshisha University
Institute
Department
Personal name
Funding Source
Organization
CONCORD CO.,LTD
HIKAWA 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
| 2014 | Year | 01 | Month | 14 | 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
| 2013 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 10 | Day |
Last modified on
| 2016 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014938
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
