Unique ID issued by UMIN | UMIN000010459 |
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Receipt number | 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 14:13:13 |
Effect of hydrogen-rich water on chronic obstructive pulmonary disease patients: A randomized, controlled, double-blind clinical trial
Effect of hydrogen-rich water on COPD
Effect of hydrogen-rich water on chronic obstructive pulmonary disease patients: A randomized, controlled, double-blind clinical trial
Effect of hydrogen-rich water on COPD
Japan |
Chronic obstructive pulmonary disease: COPD
Pneumology |
Others
NO
To evaluate whether drinking hydrogen-rich water is effective for COPD.
Efficacy
The change of dyspnea scale, the CCQ score and the frequency of exacerbation
Pulmonary function test
SGRQ and CAT score
Oxidative and inflammatory markers
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Food |
Patients drink hydrogen-rich water 500ml/day for 1 year.
Patients drink placebo water 500ml/day for 1 year.
40 | years-old | <= |
Not applicable |
Male and Female
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.
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.
70
1st name | |
Middle name | |
Last name | Tadashi Sato |
Juntendo University, Faculty of Medicine
Department of Respiratory Medicine
2-1-1 Hongo, Bunkyo-ku, Tokyo
03-5802-1063
satotada@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Tadashi Sato |
Juntendo University, Faculty of Medicine
Department of Respiratory Medicine
3-1-3 Hongo, Bunkyo-ku, Tokyo
03-5802-1063
satotada@juntendo.ac.jp
Juntendo University, Faculty of Medicine
None
Self funding
MiZ Company Limited
NO
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)
2013 | Year | 05 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 05 | Month | 29 | Day |
2013 | Year | 07 | Month | 01 | Day |
2016 | Year | 02 | Month | 28 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 06 | Month | 15 | Day |
2016 | Year | 09 | Month | 30 | Day |
2013 | Year | 04 | Month | 09 | Day |
2016 | Year | 08 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012223
Research Plan | |
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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 |
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Research case data | |
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