UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034272
Receipt No. R000039012
Scientific Title Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.
Date of disclosure of the study information 2018/09/26
Last modified on 2018/12/04

* 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 Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.
Acronym Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.
Scientific Title Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.
Scientific Title:Acronym Examination of the Effects and Safety of Applying and Ingesting Test Products on Sliming and Blood Flow.
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine effects and safety of applying and ingesting test products on sliming and blood flow.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Indexes on sliming (waist girth, hip girth, thigh girth, calf girth, upper arm girth, thigh girth and volume with 3D imaging) (Week 0, Week 4).
Key secondary outcomes *Secondary indexes
[1]Weight, body fat percentage, BMI (Week 0, Week 4)
[2]Capillary vessel measurement (Week 0, Week 4)

*Safety
[1]Blood pressure, pulsation (Week 0, Week 4)
[2]Subject's diary (From the first day of ingestion of a test material to the last day of the test)
[3]Doctor's questions (Week 0, Week 4)

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 Treatment
Type of intervention
Food Other
Interventions/Control_1 Using of test product (2 times in a day; 4 weeks) and ingesting of test product (2 tablets in a 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
50 years-old >
Gender Female
Key inclusion criteria [1]Healthy Japanese females aged 20-50 years.
[2]Individuals whose BMI is less than 30.
[3]Individuals who worry about thigh girth.
[4]Individuals who do not have exercise habits.
[5]Individuals whose written informed consent has been obtained.
[6]Individuals who can consent a 3D imaging with a paper brassiere and pants.
[7]Individuals judged appropriate for the study by the principal.
Key exclusion criteria [1]Individuals using medical products.
[2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[5]Individuals with skin disease, such as atopic dermatitis.
[6]Individuals who have sensitive skin.
[7]Individuals who are sensitive to a test producer other foods, and medical products.
[8]Individuals who are based on average alcohol per 1 day and exceeds 60g/day.
[9]Individuals whose life style will change during the test period (ex. travel for a long time).
[10]Individuals who had a habit to use and ingest health-promoting foods, foods for specified health uses, health foods, or supplements which call for slimming effects in the past 3 months or will use or ingest those foods during the test period.
[11]Individuals who have a history to be treated with an operation to improve skin condition in the past 3 months.
[12]Individuals who are or are possibly pregnant, or are lactating.
[13]Individuals who participated in other clinical studies in the past 3 months.
[14]Individuals judged inappropriate for the study by the principal.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumio Kondo
Organization Medical Corporation Kenshokai, Fukushima Healthcare Center
Division name Head
Zip code
Address 2-12-16 Tamagawa Fukushima-ku Osaka-shi Osaka 553-0004, JAPAN
TEL +81-6-6441-6848
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoma Shimizu
Organization TES Holdings Co., Ltd.
Division name Administrative Department of Clinical Trials
Zip code
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL +81-3-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization SHIRATORI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor DRC Co., Ltd.
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
2018 Year 09 Month 26 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
2018 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 27 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
2018 Year 09 Month 26 Day
Last modified on
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039012

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.