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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000041975 |
Receipt No. | R000047911 |
Scientific Title | Examination of foods ingestion containing plant extract 1 |
Date of disclosure of the study information | 2020/10/02 |
Last modified on | 2020/10/02 |
Basic information | ||
Public title | Examination of foods ingestion containing plant extract 1 | |
Acronym | Examination of foods ingestion containing plant extract 1 | |
Scientific Title | Examination of foods ingestion containing plant extract 1 | |
Scientific Title:Acronym | Examination of foods ingestion containing plant extract 1 | |
Region |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the effects of plant extract on skin and health condition. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | blood component |
Key secondary outcomes | subjective evaluation |
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 | No need to know |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Ingestion of placebo food for 4 weeks | |
Interventions/Control_2 | Ingestion of active food for 4 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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1. Healthy female aged from 25 to 39 years old
2. Subjects who have dry skin. 3. Subjects who are aware of the inelasticity of the skin 4. Subjects who are aware of skin dullness 5. Subjects who are aware of wrinkles on her skin 6. Menstrual cycle is stable 7. Subjects who can forbid intaking supplements. |
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Key exclusion criteria | 1. Subjects who have been suffered from bronchial asthma, allergic rhinitis, conjunctivitis, and atopic dermatitis
2. Subjects who have the rash resulting from psoriasis or skin allergy 3. Subjects who are outpatients or were treated by doctor recently. 4. Subjects who are using external preparations and/or moisturizer for face and arm 5. Subjects who take medicine 6. Subjects who have received or prohibit a cosmetic medicine (cosmetic surgery, injection of collagen, etc.) in face and arm 7. Subjects who have possibilities for emerging allergy to foods and drugs. 8. Subjects who are pregnant or lactating, or planned to become pregnant in the near future. 9. Current smoker 10. Subjects who are participate in the other clinical studies 11. Subjects who are judged as unsuitable for the study by the investigator for other reason. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kao Corporation | ||||||
Division name | Skin Care Products Research | ||||||
Zip code | 131-8501 | ||||||
Address | 2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, Japan | ||||||
TEL | 81-(0)3-5630-9581 | ||||||
suma.akane@kao.com |
Public contact | |||||||
Name of contact person |
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Organization | C&C Corporation | ||||||
Division name | C&C Corporation | ||||||
Zip code | 104-0045 | ||||||
Address | 4-7-5, Tukiji, Chuo-ku, Tokyo, 104-0045, JAPAN | ||||||
TEL | 81-(0)3-3545-3781 | ||||||
Homepage URL | |||||||
m.mizuuchi@candc.co.jp |
Sponsor | |
Institute | Kao Corporation |
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 | Human Reserch Ethics Committee, Kao Corporation |
Address | 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN |
Tel | +81-3-5630-7263 |
morisaki.naoko@kao.com |
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 | 築地クリニック(東京都) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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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=R000047911 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |