UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026913 |
|---|---|
| Receipt number | R000027073 |
| Scientific Title | Human clinical trial aimed at evaluating antioxidative effect and safety of Hydrogen Coral Powder |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2017/06/15 20:17:41 |
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Basic information
Public title
Human clinical trial aimed at evaluating antioxidative effect and safety of Hydrogen Coral Powder
Acronym
Human clinical trial of Hydrogen Coral Powder
Scientific Title
Human clinical trial aimed at evaluating antioxidative effect and safety of Hydrogen Coral Powder
Scientific Title:Acronym
Human clinical trial of Hydrogen Coral Powder
Region
| Japan |
Condition
Condition
Adults in good health condition
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate antioxidative effect and safety of Pure Ash Coral (label name of the material: Hydrogen Coral Powder).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Intake method: 2g daily
Intake period: 6 months
Measuring method:
blood pressure check, pulse check, body temperature check
Blood test, Measuring 8-OHdG creatinine ratio in urine.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake 2g of Hydrogen Coral Powder (Pure Ash Coral) per day (1g before breakfast and 1g before dinner) for 6 months.
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Not under 20 years old when giving consent.
Critical hepatic dysfunction and/or critical renal dysfunction not to be observed at screening test.
Person who give first-person consent in writing.
Key exclusion criteria
Person who are obviously not able to visit hospital during the trial.
Person whom doctor-in-charge judges the one is unsuitable for this trial.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Yoshimura |
Organization
Clinic Shinkenan
Division name
Director
Zip code
Address
4-18-10 Takanawa, Minato-ku, Tokyo
TEL
03-6447-7818
clinic.shinkenan@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Ido |
Organization
First CO., Ltd.
Division name
Sales Department
Zip code
Address
5-7-14, Kitashinagawa, Shinagawa-ku, Tokyo
TEL
03-5475-8967
Homepage URL
info@suiso1st.co.jp
Sponsor or person
Institute
First CO., Ltd.
Institute
Department
Personal name
Funding Source
Organization
First Co., Ltd.
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
Address
Tel
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
クリニック真健庵（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In the case of 10 subjects, whose 8-OHdG creatinine ratios were not less than 20ng/mg CRE (strong DNA damage) before intake of Pure Ash Coral (Hydrogen Coral Powder), 6 months after the first intake the mean of 8-OHdG creatinine ratios of 10 subjects were reduced by significant difference. The reduction of 8-OHdG creatinine ratios suggests that Pure Ash Coral has oxidative stress elimination effect.
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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 09 | Day |
Last modified on
| 2017 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027073
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
