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 2016/07/28 10:09:23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Hiromu Ohnogi

Organization

Takara Bio Inc.

Division name

CDM center

Zip code


Address

7-4-38 Nojihigashi, Kusatsu, Shiga, Japan

TEL

077-567-9266

Email

onogih@takara-bio.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Sakurai

Organization

imeQ.Inc

Division name

CRO Division

Zip code


Address

2-14-6 Nishi-waseda, Sinjyuku-ku, Tokyo. 169-0075

TEL

03-6205-6222

Homepage URL


Email

s-sakurai@imeq.co.jp


Sponsor or person

Institute

imeQ 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


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

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

2016 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023959


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name