UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020760 |
|---|---|
| Receipt number | R000023959 |
| Scientific Title | The effectiveness of Dioscorea esculenta on physical functions. |
| Date of disclosure of the study information | 2016/01/27 |
| Last modified on | 2024/05/21 14:55:50 |
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Basic information
Public title
The effectiveness of Dioscorea esculenta on physical functions.
Acronym
The effectiveness of Dioscorea esculenta on physical functions.
Scientific Title
The effectiveness of Dioscorea esculenta on physical functions.
Scientific Title:Acronym
The effectiveness of Dioscorea esculenta on physical functions.
Region
| Japan |
Condition
Condition
Muscle fatigue
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness ofDioscorea esculenta on physical functions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS Questionnaire
In the blood lactate levels
Creatinine kinase
Myoglobin, BUN, GOT, GPT, LDH, potassium
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
Test food
Interventions/Control_2
Placebo food
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
20<=age<=30
Male
Outpatients
Healthy adults
Non smoker
Those who are able to obtained consent document
Key exclusion criteria
Those who have an abnormality in the motor function.
Those who cannot avoid drinking the day before the study.
Those who have an allergy of Yam.
Those who were participating in other clinical trials within one month or those who are currently participating in other clinical trials
Those who may suffer any risk from the study.
Those who may not provide enough data.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hiromu |
| Middle name | |
| Last name | Ohnogi |
Organization
Takara Bio Inc.
Division name
CDM center
Zip code
525-0058
Address
7-4-38 Nojihigashi, Kusatsu, Shiga, Japan
TEL
077-567-9266
onogih@takara-bio.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Takara Bio Inc.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.jp
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
| 2016 | Year | 01 | Month | 27 | 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
| 2015 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 28 | 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
| 2016 | Year | 01 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023959
