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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025263
Receipt No. R000029059
Scientific Title A verification study on swelling reduction effect by plant-derived ingredients containing food
Date of disclosure of the study information 2018/02/28
Last modified on 2017/05/02

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Basic information
Public title A verification study on swelling reduction effect by plant-derived ingredients containing food
Acronym A verification study on swelling reduction effect by plant-derived ingredients containing food
Scientific Title A verification study on swelling reduction effect by plant-derived ingredients containing food
Scientific Title:Acronym A verification study on swelling reduction effect by plant-derived ingredients containing food
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects on the facial swelling after drinking alcohol by test food
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Subjective symptoms for swelling: questionnaire
Key secondary outcomes 1. Leg swelling
Water tank volume immersion and calf circumference

2. Facial swelling
High resolution analyzed image, moisture, oiliness, skin tone, pigmentation (the number of pigmentations and total area of pigmentations), pores, wrinkle (the number of wrinkles and total length and areas), texture

3. Subjective symptoms related to swelling of health: questionnaire

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
Interventions/Control_1 1. Single-dose study
Test materials: 50 mg of plant-derived ingredients containing tablets
Duration: 1 day
Administration: After two hours at intake 8 tablets of the test food, measure swelling
*Drink 350 mL of beer with alcohol content of 5% at night before the examination day

2. Continuation-dose study
Test materials: 50 mg of plant-derived ingredients containing tablet
Duration: 1 week
Administration: Take 8 tablets of the test food per day any time during the day
*Drink 350 mL of beer with alcohol content of 5% at night before the examination day
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

Not applicable
Gender Female
Key inclusion criteria 1. Healthy adults Japanese women

2. Those who received a full explanation of the procedures in the study, and informed consent was documented and signed by all of the participants
Key exclusion criteria 1. To diagnose kidney function works abnormity (urine proteins, creatinine etc. as biomarker) by urinalysis

2. Diastolic pressure is more than 135 mmHg

3. Those who are allergic to citrus fruits

4. Those who are pregnant, breast-feeding, or are expected to become pregnant during the test period

5. Those who had and plan to have surgery and/or hospitalization within 2 months before and after the study period of Nov. 2016 to May 2017

6. Others consider as inappropriate for this test by the physician
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko YOSHIKAWA
Organization SAPPORO HOLDINGS LTD.
Division name Group Research and Development Division
Zip code
Address 4-20-1 Ebisu, Shibuya-ku, Tokyo.
TEL 03-5795-1201
Email Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko YOSHIKAWA
Organization SAPPORO HOLDINGS LTD.
Division name Group Research and Development Division
Zip code
Address 4-20-1 Ebisu, Shibuya-ku, Tokyo.
TEL 03-5795-1201
Homepage URL
Email Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp

Sponsor
Institute SAPPORO HOLDINGS LTD.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 サッポロホールディングス株式会社本社(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 28 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
2016 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 12 Day
Last follow-up date
2017 Year 02 Month 28 Day
Date of closure to data entry
2017 Year 05 Month 31 Day
Date trial data considered complete
2017 Year 05 Month 31 Day
Date analysis concluded
2017 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2017 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029059

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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