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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027055
Receipt No. R000031014
Scientific Title Validation study for effect of Hydrogen Coral Powder (Pure Ash Coral) to ammonia in the blood
Date of disclosure of the study information 2017/04/19
Last modified on 2017/04/18

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Basic information
Public title Validation study for effect of Hydrogen Coral Powder (Pure Ash Coral) to ammonia in the blood
Acronym Validation study for effect of Hydrogen Coral Powder (Pure Ash Coral) to ammonia in the blood
Scientific Title Validation study for effect of Hydrogen Coral Powder (Pure Ash Coral) to ammonia in the blood
Scientific Title:Acronym Validation study for effect of Hydrogen Coral Powder (Pure Ash Coral) to ammonia in the blood
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effect of health food "Hydrogen Coral Powder (Pure Ash Coral)" to ammonia in the blood in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intake method: 2g daily
Intake period: 3 months
Test point: 0 week, 2 weeks, 2 months, 3
months
Measuring method: Blood test
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Period: 3 months
Test food: Hydrogen Coral Powder (Pure Ash Coral)
Dose: Intake 2g of Hydrogen Coral Powder a day
Usage: Intake 1g of Hydrogen Coral Powder with
water before meal (breakfast and dinner)
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
60 years-old >
Gender Male and Female
Key inclusion criteria Not under 40 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 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Yano
Organization First Co.,Ltd.
Division name Director
Zip code
Address 5-7-14, Kitashinagawa, Shinagawa-ku, Tokyo
TEL 03-5475-8967
Email info@suiso1st.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makiko Ido
Organization First Co.,Ltd.
Division name Planning Office
Zip code
Address 5-7-14, Kitashinagawa, Shinagawa-ku, Tokyo
TEL 03-5475-8967
Homepage URL
Email info@suiso1st.co.jp

Sponsor
Institute First Co.,Ltd.
Institute
Department

Funding Source
Organization First Co.,Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 19 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
2015 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 25 Day
Last follow-up date
2016 Year 04 Month 27 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 18 Day
Last modified on
2017 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031014

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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