Unique ID issued by UMIN | UMIN000023634 |
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Receipt number | R000027219 |
Scientific Title | Safety of mucuna sheets in healthy senior subjects |
Date of disclosure of the study information | 2016/08/16 |
Last modified on | 2017/09/26 12:30:34 |
Safety of mucuna sheets in healthy senior subjects
Safety of mucuna sheets in healthy senior subjects
Safety of mucuna sheets in healthy senior subjects
Safety of mucuna sheets in healthy senior subjects
Japan |
healthy senior subjects
Adult |
Others
NO
To evaluate the safety of mucuna sheets in general elderly people by using the pharmacokinetics of levodopa level and the data collected from vital sign and daily medical practice.
Safety
Exploratory
Pragmatic
Phase I
Pharmacokinetics parameter of blood levodopa levels
Hypotensive effect, fatigue improved work,
the Clinical Global Impressions (CGI) -ImprovementScale
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
YES
2
Prevention
Food |
We compare the blood kinetics with the group taken two pieces mucuna sheets (food processing thing) and four pieces.
For the next 12 weeks, we examine safety taken six pieces per a day.
60 | years-old | <= |
80 | years-old | > |
Male and Female
general elderly people
The patients with Parkinson's disease
The patients treated for thing antipsychotics treated for an antiparkinson agent
There are a serious heart, lung, liver, renal dysfunction
More than systolic blood pressure 180mmHg
More than BMI 30
More than HbA1c 8.0
It is less than 8.0 mg/dl of hemoglobin,
Less than 20000 platelet /mm3
AST, ALT, LDH, ALP, gGTP, BUN, a Cre level are less than eGFR 30ml/min more than 3 times of the normal upper limit level
The AV block where is atrial fibrillation, 2 degrees or more with an electrocardiogram,
the patients with a history of treatment of the malignant tumor within thing with the malignant tumor, the past five years
20
1st name | |
Middle name | |
Last name | Noriko Nishikawa |
Ehime University Graduate School of medicine
Neurology and Clinical pharmacology
454 Shitsukawa Tohon Ehime
089-960-5095
n-nishi@m.ehime-u.ac.jp
1st name | |
Middle name | |
Last name | Noriko Nishikawa |
Ehime University Graduate School of medicine
Neurology and Clinical pharmacology
454 Shitsukawa Tohon Ehime
089-960-5095
n-nishi@m.ehime-u.ac.jp
Ehime University Graduate School of medicine
Neurology and Clinical pharmacology
Kishu Hosokawa
Profit organization
NO
2016 | Year | 08 | Month | 16 | Day |
Published
The maximum plasma concentration (Cmax) of L-dopa of the groups which received two sheets and four sheets of mucuna were 137.4 nM and 483.0nM, respectively. The individual variability of plasma concentration is around eight fold. Subjects showed no adverse reactions except slight sleepiness. Although there were significant differences in renal function and blood glucose level during 12 weeks of mucuna treatment, they do not impose any clinically important meaning and they are also considered not to be related with ingestion of mucuna sheet.
Completed
2016 | Year | 07 | Month | 25 | Day |
2016 | Year | 08 | Month | 16 | Day |
2016 | Year | 12 | Month | 31 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 04 | Month | 10 | Day |
2017 | Year | 07 | Month | 31 | Day |
2016 | Year | 08 | Month | 15 | Day |
2017 | Year | 09 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027219
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