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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031184
Receipt No. R000035601
Scientific Title Examination of drink ingestion containing plant extract. NT-18002
Date of disclosure of the study information 2018/02/14
Last modified on 2018/08/09

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Basic information
Public title Examination of drink ingestion containing plant extract. NT-18002
Acronym Examination of drink ingestion containing plant extract. NT-18002
Scientific Title Examination of drink ingestion containing plant extract. NT-18002
Scientific Title:Acronym Examination of drink ingestion containing plant extract. NT-18002
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of plant extract on vascular function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin temperature.
Key secondary outcomes Peripheral blood flow and subjective evaluation.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Drink containing plant extract (single ingestion)->washout period->placebo drink not containing plant extract (single ingestion)
Interventions/Control_2 Placebo drink not containing plant extract (single ingestion)->washout period->Drink containing plant extract (single ingestion)
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
35 years-old >=
Gender Female
Key inclusion criteria 1.Healthy adults
2.Person whose estradiol cycle is stable between 28 and 32 days.
3.Person who is sensitive to cold.
4.Person who agrees not to ingest specified foods and supplements during the test period.
Key exclusion criteria 1.Person whose body math index is less than 18.5 or more than 25.0.
2.Person whose diastolic blood pressure is more than 90mmHg and systolic one is more than 140mmHg.
3.Person who has severe allergic disease as rhinitis, atopic dermatitis.
4.Person who is pregnant, lactating or planned to become pregnant during the test period.
5.Patient with vascular function disorder.
6.Person who has problems with electrocardiogram test such as arrhythmia.
7.Person who takes medicine.
8.Person who regularly goes to hospital or went to the medical institution within a month.
9.Current smoker.
10.Person who plans to participate in the other clinical studies.
11.Person who is judged as unsuitable for the study by the investigator for other reasons.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akane Suma
Organization Kao Corporation
Division name R&D-Skin Care Products Research
Zip code
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL +81-3-5630-9581
Email suma.akane@kao.com

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 University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, 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 Kao 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
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 株式会社TESホールディングス(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 02 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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 14 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 02 Month 07 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035601

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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