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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031609
Receipt No. R000036082
Scientific Title A verification study of the reduction on swollen face with the intake of lemon-derived polyphenol (enzyme-treated hesperidin): a randomized, double-blind, placebo-controlled, crossover trial
Date of disclosure of the study information 2018/03/06
Last modified on 2018/08/21

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Basic information
Public title A verification study of the reduction on swollen face with the intake of lemon-derived polyphenol (enzyme-treated hesperidin): a randomized, double-blind, placebo-controlled, crossover trial
Acronym A verification study of the reduction on swollen face with the intake of lemon-derived polyphenol (enzyme-treated hesperidin)
Scientific Title A verification study of the reduction on swollen face with the intake of lemon-derived polyphenol (enzyme-treated hesperidin): a randomized, double-blind, placebo-controlled, crossover trial
Scientific Title:Acronym A verification study of the reduction on swollen face with the intake of lemon-derived polyphenol (enzyme-treated hesperidin)
Region
Japan

Condition
Condition Healthy Japanese adult people
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the reduction on swollen face by test food
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Subjective symptoms on swollen face

* Visual Analogue Scale (VAS)
* Assessed the item once at screening and in the morning and evening of intervention 1 and 2 before intake and 2 weeks after intake
Key secondary outcomes 1. Wrinkles on facial skin
2. Prominences on facial skin
3. Hemoglobin concentration on facial skin
4. Melanin concentration on facial skin
5. Facial volume
6. Facial dermal water content
7. Leg volume
8. Calf circumference
9. Subjective symptoms
10. Blood pressure

*1-4 Measured by ANTERA 3D
*5 Measured by VECTRA H1
*6 Measured by MoistureMeter D
*7 Measured leg volume by a measuring device
*8 Use a measuring tape
*9 Assessed subjective symptoms by VAS
*1-8 Assessed the items once at screening and in the morning and evening of intervention 1 and 2 before intake and 2 weeks after intake
*9 Assessed the items in the morning and evening of intervention 1 and 2 before intake and 2 weeks after intake
*10 Assessed the items once at screening and in the morning of intervention 1 and 2 before intake and 2 weeks after intake

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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 [1]
Duration: 2 weeks
Test material: Tablets containing lemon-derived, enzyme-treated hesperidin
Administration: Take one tablet after dinner
* If you forget to take the tablet, take it in the day.

[2]
Washout period is for 2 weeks

[3]
Duration: 2 weeks
Test material: Placebo
Administration: Take a tablet after dinner
* If you forget to take the tablet, take it in the day.
Interventions/Control_2 [1]
Duration: 2 weeks
Test material: Placebo
Administration: Take a tablet after dinner
* If you forget to take the tablet, take it in the day.

[2]
Washout period is for 2 weeks

[3]
Duration: 2 weeks
Test material: Tablets containing lemon-derived, enzyme-treated hesperidin
Administration: Take a tablet after dinner
* If you forget to take the tablet, take it in the day.
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 Male and Female
Key inclusion criteria 1. Healthy Japanese adult people who are suffering from facial swelling in daily

2. Subjects who are judged as eligible to participate in the study by the physician

3. Subjects who are not detected any renal dysfunction by urinalysis at screening

4. Subjects whose systolic blood pressure is below 130 mmHg at screening

5. Within the subjects who met 2nd to 4th inclusion criteria, select subjects with relatively high score in VAS related to facial swelling at screening
Key exclusion criteria 1. A medical history of malignant tumor, heart failure or myocardial infarction

2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

4. Currently taking medicines (include herbal medicines) and supplements

5. Subjects who are allergic to medicines and/or the test food related products
* Particularly citrus fruits allergy

6. Subjects whose body mass index (BMI) is less than 18.5 kg/m2 or 30 kg/m2 or more

7. Subjects who work late-night shift or are irregular of their life-styles

8. Subjects who are pregnant, lactation, and planning to become pregnant

9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization SAPPORO HOLDINGS LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
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 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 06 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 03 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 06 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 03 Month 06 Day
Last modified on
2018 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036082

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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