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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Healthy Japanese adult people | ||
Classification by specialty |
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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 |
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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. |
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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. |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
kazu@orthomedico.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Results | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Management information | |||||||
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Last modified on |
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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 |