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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027700
Receipt No. R000031724
Scientific Title A clinical study to evaluate the anti-fatigue effect of hydrogen water
Date of disclosure of the study information 2018/11/30
Last modified on 2018/12/27

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Basic information
Public title A clinical study to evaluate the anti-fatigue effect of hydrogen water
Acronym The anti-fatigue effect of hydrogen water
Scientific Title A clinical study to evaluate the anti-fatigue effect of hydrogen water
Scientific Title:Acronym The anti-fatigue effect of hydrogen water
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the anti-fatigue effect of hydrogen water: a randomized, double-blind, placebo-controlled, crossover study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analogue scale (VAS)
Key secondary outcomes Advanced trail making test (ATMT) , Chalder fatigue scale, autonomic nervous system function(spectrum analysis of a-a intervals on accelerated plethysmography), d-ROMs, BAP, OSI, hs-CRP, ox-LDL, cortisol, urinary 8-isoprostane, urinary 8-OHdG

Base
Study type Interventional

Study design
Basic design Cross-over
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 Treatment
Type of intervention
Food
Interventions/Control_1 Intake of Test food (4 weeks) -> Washout (4 weeks) -> Intake of Placebo (4 weeks)
Interventions/Control_2 Intake of Placebo (4 weeks) -> Washout (4 weeks) -> Intake of Test food (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
30 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy subjects aged from 30 to 60 years (bounds included)
2) Subject whose serum d-ROMs level between 301 U.CARR to 400 U.CARR (bounds included)
3) Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria 1) Subject receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subject having the chronic fatigue syndrome (CFS), or subject deemed to have severe fatigue such as idiopathic chronic fatigue by the investigator
3) Subject who takes regularly medicine or quasi-drugs which having the efficacy on recovery of fatigue or nutrition in cases of physical fatigue
4) Subject who regularly takes hydrogen water
5) Subject having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
6) Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
7) Female subject who is pregnant or lactating, or intending to become pregnant during the study
8) Subject deemed unsuitable by the investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osami Kajimoto
Organization Osaka City University Graduate School of Medicine
Division name Department of Medical Science on Fatigue
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL 06-6645-6171
Email kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name Representative Director
Zip code
Address Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi,Toyonaka,Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

Funding Source
Organization Melodian 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
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 医療法人弘正会ふくだ内科クリニック

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 30 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
2017 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 09 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031724

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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