Unique ID issued by UMIN | UMIN000007497 |
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Receipt number | R000008832 |
Scientific Title | Trial of molecular hydrogen water in Parkinson disease |
Date of disclosure of the study information | 2012/03/14 |
Last modified on | 2013/01/07 23:09:51 |
Trial of molecular hydrogen water in Parkinson disease
Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in Parkinson Disease
Trial of molecular hydrogen water in Parkinson disease
Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in Parkinson Disease
Japan |
Parkinson disease
Neurology |
Others
NO
To determine that intake of molecular hydrogen water is safe and a disease-modifying treatment of PD.
Safety,Efficacy
Confirmatory
Not applicable
The primary endpoint is the change from baseline to 48th week in the total score of the Unified Parkinson 's disease Scale (UPDRS).
Additional analysis
1.The change of UPDRS part II, III, and Hoehn and Yahr staging from baseline to 8, 24, 48 weeks and post 8th weeks. The changes of total score of UPDRS from baseline to 8th, 24th, and post 8th week.
2. The duration to protocol ended because of addition of levodopa or progression of disease.
Safety analysis
1) Adverse events except dyskinesia.
2) Screening laboratory studies included level of total protein, albumin, alkaline phosphatase, aspartate transaminase, alanine transaminase, serum urea nitrogen, calcium, chloride, creatinine, glucose, lactate dehydrogenase, potassium, sodium, creatinine kinase, uric acid, choline esterase, LDL-cholestrol, HDL-cholestrol and triglyceride.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
2
Treatment
Food |
The subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks.
Placebo water which is not contained molecular hydrogen water made from pseudo-machine. The subjects consume for48 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
Inclusion criteria required that subjects had received the diagnosis of PD according to the UK Brain Bank criteria , and had rating in the modified Hoehn and Yahr staging between 1 to 4 on on-phase, and medicated with levodopa, without dementia (MMSE >= 25). Outpatients are better than admitted patietns. No change on medication for PD for four weeks. The subjects are over 20 years-old.Written informed consent must be obtained.
1. The patient with parkinsonism due to corticobasal syndrome, multiple system atrophy, drug parkinsonism, hydrocephalus, essential tremor.
2. The presence of other serious disease.
3. The presence of malignant tumor.
4. The presence of adverce event caused with dopaminagonist
5. Subjects which are inappropriate for the study according to our judgment.
18
1st name | |
Middle name | |
Last name | Asako Yoritaka |
Juntendo University School of Medicine
Neurology
Bunkyo-ku Hongo 3-1-1, Tokyo, Japan
+813-3813-3111
1st name | |
Middle name | |
Last name | Asako Yoritaka |
Juntendo University School of Medicine
Neurology
Bunkyo-ku Hongo 3-1-1, Tokyo, Japan
+813-3813-3111
Department of Neurology, Juntendo University School of Medicine
Department of Neurology, Juntendo University School of Medicine
Self funding
NO
順天堂大学医学附属順天堂医院 (東京都)
2012 | Year | 03 | Month | 14 | Day |
Unpublished
The total UPDRS score of the H2-water group (n = 9) improved-1.0 (median), -5.7+- 8.4 (mean +- SD)], whereas that of the placebo group (n = 8) worsened [4.5, 4.1 +- 9.2]. Despite the minimal number of subjects and the short duration of the trial, the difference was significant (P < 0.05).
Conclusion: Drinking H2-water was safe and well tolerated and improved PD significantly.
Completed
2009 | Year | 10 | Month | 27 | Day |
2010 | Year | 01 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2012 | Year | 03 | Month | 13 | Day |
2013 | Year | 01 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008832
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