UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042802 |
|---|---|
| Receipt number | R000048867 |
| Scientific Title | Validation research about operations of eyelid-absorbed H2 percutaneously on the eyes, the face and the central nerves |
| Date of disclosure of the study information | 2021/12/25 |
| Last modified on | 2021/05/21 12:22:50 |
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Basic information
Public title
Validation research about operations of eyelid-absorbed H2 percutaneously on the eyes, the face and the central nerves
Acronym
Validation research about operations of eyelid-absorbed H2 percutaneously on the eyes, the face and the central nerves
Scientific Title
Validation research about operations of eyelid-absorbed H2 percutaneously on the eyes, the face and the central nerves
Scientific Title:Acronym
Validation research about operations of eyelid-absorbed H2 percutaneously on the eyes, the face and the central nerves
Region
| Japan |
Condition
Condition
Healthy female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify some kind of operation on eyes, the face and the central nerves, which could be induced by percutaneously absorption of an apparatus-generated H2 around eyes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Facial blood flow
2. Dynamic visual acuity
3. Flicker
4. Mental age
Key secondary outcomes
1. Oxytocin in saliva
2. Multiple measurements of emotion using a multiple mood scale (short ver.)
3. Brain waves (2 ch)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Infusion of the test apparatus-generated hydrogen into the subject's eyelids with the close eye for 5 min.
Interventions/Control_2
Infusion of the air equivalent to the above-mentioned hydrogen into the subject's eyelids with the close eye for 5 min.
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy female subjects ranging in age from 20 to 39, at the moment of giving informed consent to take part in this trial.
(2) Subjects equipped with asthenopia and daily stress.
(3) Subjects who can give informed consent to participate in this research after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects falling into the habit of smoking.
(2) Subjects with the condition of being over-sensitiveness to cold, even during the summer season.
(3) Subjects taking steadily in the medicine and/or the health-specific/functional/health foods, which might affect their blood flow improvement.
(4) Subjects with some kind of eye disease in and around their eyes/eyelids.
(5) Pregnant, possibly pregnant, or lactating women.
(6) Subjects having previous/present medical history of serious diseases in heart, liver, kidney, and/or digestive organs.
(7) Subjects with some kind of skin symptom, disease or disorder, just like atopic dermatitis.
(8) Subjects who have undergone some kind of surgical treatment for the measurement region, within the last six months into this trial.
(9) Subjects with high blood pressure-- a maximal blood pressure of not less than 160 mmHg, a minimal blood one of not less than 100 mmHg--, and so on.
(10) Subjects who realized that the subjects themselves must be in a state of menopausal disorder.
(11) Subjects who are now under the other clinical tests with some kind of medicine/food, or took part in those within four weeks before this trial, or are planning to participate in those after giving informed consent to take part in this trial.
(12) Others who have been determined as ineligible for participation, judging from the investigator's opinions.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Aqua Bank
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Integrative and Global Majors, Tsukuba University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 25 | 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
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048867
