Unique ID issued by UMIN | UMIN000032701 |
---|---|
Receipt number | R000037292 |
Scientific Title | Prospective, randomized, open-label,clinical trial comparing the effects of hydrogen tablet and placebo on blood and urine makers for cardiovascular diseases |
Date of disclosure of the study information | 2019/05/24 |
Last modified on | 2021/11/26 17:31:33 |
Prospective, randomized, open-label,clinical trial comparing the effects of hydrogen tablet and placebo on blood and urine makers for cardiovascular diseases
Effects of hydrogen tablet on blood and urine makers
Prospective, randomized, open-label,clinical trial comparing the effects of hydrogen tablet and placebo on blood and urine makers for cardiovascular diseases
Effects of hydrogen tablet on blood and urine makers
Japan |
cardiovascular disease, diabetes and dyslipidemia
Medicine in general |
Others
NO
To compare effects of hydrogen tablet and placebo on blood and urine biomakers for cardiovascular diseases
Efficacy
Markers indicating oxidative stress (Oxidized albumin, isoprostane, 8-OHdG, MDA-LDL, FABP)
4 weeks after administration
Blood lipids, glucose, HbA1c
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), and early-staged kidney diseases (microalbuminuria)
4 weeks after administration
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Medicine |
hydrogen tablet 2tab/day for 4 weeks
>
placebo 2tab/day for 4 weeks
placebo 2tab/day for 4 weeks
>
hydrogen tablet 2tab/day for 4 weeks
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Patients with cardiovascular diseases, diabetes and dyslipidemia
2) Out patients
1) Poor-controlled hypertension (DBP>110)
2) Poor-controlled diabetes (HbA1c>8.0 %)
3) Secondary hypertension
4) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
5) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
6) End stage renal disease
7) Symptomatic (NYHA III or IV) congestive heart failure
8) Malignancies or other diseases with poor prognosis
9) Subjects whose doctor in charge do not agree to join the trial
30
1st name | Makoto |
Middle name | |
Last name | Ayaori |
Tokorozawa Heart Center
Shintokoekimae Clinic
3591111
1-4-1 Midoricho Tokorozawa Japan 359-1111
04-2929-1801
ayaori@ba2.so-net.ne.jp
1st name | Makoto |
Middle name | |
Last name | Ayaori |
Tokorozawa Heart Center
Shintokoekimae Clinic
3591111
1-4-1 Midoricho Tokorozawa Japan 359-1111
04-2929-1801
ayaori@ba2.so-net.ne.jp
Tokorozawa Heart Center
Foundation for Promotion of Defense Medicine
Other
Tokorozawa Heart Center IRB
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
04-2940-8611
cs.thc@oukai.or.jp
NO
2019 | Year | 05 | Month | 24 | Day |
Unpublished
No longer recruiting
2018 | Year | 05 | Month | 16 | Day |
2018 | Year | 04 | Month | 18 | Day |
2018 | Year | 05 | Month | 24 | Day |
2023 | Year | 03 | Month | 31 | Day |
2018 | Year | 05 | Month | 24 | Day |
2021 | Year | 11 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037292
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |