UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053005 |
|---|---|
| Receipt number | R000060454 |
| Scientific Title | Verification of the effects of test food intake on itchy skin : Placebo-controlled, double-blind, randomized, parallel-group comparison study |
| Date of disclosure of the study information | 2023/12/07 |
| Last modified on | 2024/12/02 18:47:58 |
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Basic information
Public title
Verification of the effects of test food intake on itchy skin
Acronym
Verification of the effects of test food intake on itchy skin
Scientific Title
Verification of the effects of test food intake on itchy skin
: Placebo-controlled, double-blind, randomized, parallel-group comparison study
Scientific Title:Acronym
Verification of the effects of test food intake on itchy skin
: Placebo-controlled, double-blind, randomized, parallel-group comparison study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ingest the test food for 4 weeks and verify the effect on the immune index during exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food for 8 weeks
Interventions/Control_2
Ingestion of placebo food for 8 weeks
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjects of men and women aged 20 to 64
(2) Subject suffering from itchy and dry skin
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria
(1) Subjects with skin diseases (e.g. atopic dermatitis) according to physician's findings
(2) Subjects with diabetes mellitus, liver disease, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, disease affecting the secretion of adrenal corticosteroids, or other serious diseases, or with pre-existing diseases.
(3) Subjects who have undergone gastrointestinal surgery
(4) Subjects with diseases currently being treated, or for whom treatment is deemed necessary by the principal investigator or research assistants.
(5) Subjects who are allergic to food (especially gelatin) and drugs
(6) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects.
(7) Subjects who habitually engage in strenuous sports such as marathon running (including professional athletes) and subjects on a diet
(8) Subjects with extremely irregular eating habits
(9) Subjects who may be exposed to excessive ultraviolet light during the study period.
(10) Subjects who visit beauty salons for skin care
(11) Subjects who are unable to discontinue consumption of health foods (including food for specified health uses, functional foods, and supplements) and designated quasi-drugs during the study period.
(12) Subjects who continue to receive treatment with drugs (including OTC and prescription drugs, e.g., antihistamines, antiallergic agents, cold remedies, topical steroids, etc.) that affect immunity or skin itching or that affect the results of the study (e.g., hypo sensitization therapy)
(13) Subjects who have a habit of consuming foods rich in acetic acid bacteria (nigori vinegar, etc.), foods rich in lactic acid bacteria or bifidobacteria (lactic acid bacteria drinks, yogurt, kimchi, etc.), or lactic acid bacteria preparations at least 3 times a week.
(14) to (20) are listed in the "Other related information" column.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Miura Clinic, Medical Corporation Kanonkai
Division name
Internal medicine
Zip code
5300044
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-6135-5200
info@miura-cl.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical Trial Division
Zip code
5300044
Address
Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka
TEL
06-4801-8917
Homepage URL
mterashima@oneness-sup.co.jp
Sponsor or person
Institute
Miura Clinic, Medical Corporation Kanonkai
Institute
Department
Personal name
Funding Source
Organization
Kewpie 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
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka
Tel
06-6135-5200
mterashima@miura-cl.jp
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
医療法人花音会みうらクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 07 | 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
| 2023 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
"Key exclusion sriteria"
(14) Subjects who work day and night shifts or engage in physical labor such as heavy lifting
(15) Subjects who are unable to perform the testing procedures to be conducted during the study period as specified (e.g., questionnaire responses)
(16) Subjects who plan to travel abroad during the research period
(17) Subjects who drink more than 20 g of average daily pure alcohol
(18) Subjects who smoke an average of 21 or more cigarettes per day
(19) Subjects who are participating in or will participate in other clinical trials at the start of this study.
(20) Other subjects judged by the investigator or the investigator to be inappropriate for the examination
Management information
Registered date
| 2023 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060454
