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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010459
Receipt No. R000012223
Scientific Title Effect of hydrogen-rich water on chronic obstructive pulmonary disease patients: A randomized, controlled, double-blind clinical trial
Date of disclosure of the study information 2013/05/01
Last modified on 2016/08/29

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Basic information
Public title Effect of hydrogen-rich water on chronic obstructive pulmonary disease patients: A randomized, controlled, double-blind clinical trial
Acronym Effect of hydrogen-rich water on COPD
Scientific Title Effect of hydrogen-rich water on chronic obstructive pulmonary disease patients: A randomized, controlled, double-blind clinical trial
Scientific Title:Acronym Effect of hydrogen-rich water on COPD
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease: COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether drinking hydrogen-rich water is effective for COPD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of dyspnea scale, the CCQ score and the frequency of exacerbation
Key secondary outcomes Pulmonary function test
SGRQ and CAT score
Oxidative and inflammatory markers

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Patients drink hydrogen-rich water 500ml/day for 1 year.
Interventions/Control_2 Patients drink placebo water 500ml/day for 1 year.
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. FEV1/FVC < 0.7 and FEV1 < 80% predicted (Grade 2-4 of classification of severity in the GOLD guideline)
2. Patients who are complain of dyspnea continuously.
3. Patients who can perform pulmonary function test.
4. Patients without disturbance of swallowing.
5. Male and female patients aged 40 years or older with any smoking histories.
6. Patients who go to the outpatient clinic regularly.
7. Patients who can acquire a document agreement.
Key exclusion criteria 1. Patients who is complicated with chronic respiratory disease except COPD.
2. Patients with disturbance of swallowing
3. Patients who cannot understand how to drink a sample safety.
4. Patients with severe comorbidities
5. Patients who receive treatments of severe diseases such as cancers
6. Patients who are pregnant and nursing, and hope to be pregnant.
7. Patients who has a past history of severe allergy.
8. In addition, patients who judged that the examination medical attendant was inappropriate.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Sato
Organization Juntendo University, Faculty of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5802-1063
Email satotada@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Sato
Organization Juntendo University, Faculty of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-5802-1063
Homepage URL
Email satotada@juntendo.ac.jp

Sponsor
Institute Juntendo University, Faculty of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor MiZ Company Limited
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 順天堂大学医学部附属順天堂医院(東京都)、順天堂大学医学部附属静岡病院(静岡県)、順天堂大学医学部附属浦安病院(千葉県)、越谷市立病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 01 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
2013 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2016 Year 02 Month 28 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 06 Month 15 Day
Date analysis concluded
2016 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 09 Day
Last modified on
2016 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012223

Research Plan
Registered date File name
2016/04/12 COPD水素水臨床試験実施計画書第4版(変更版).docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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