UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023634
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Safety of mucuna sheets in healthy senior subjects
Acronym Safety of mucuna sheets in healthy senior subjects
Scientific Title Safety of mucuna sheets in healthy senior subjects
Scientific Title:Acronym Safety of mucuna sheets in healthy senior subjects
Region
Japan

Condition
Condition healthy senior subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Pharmacokinetics parameter of blood levodopa levels
Key secondary outcomes Hypotensive effect, fatigue improved work,
the Clinical Global Impressions (CGI) -ImprovementScale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 We compare the blood kinetics with the group taken two pieces mucuna sheets (food processing thing) and four pieces.
Interventions/Control_2 For the next 12 weeks, we examine safety taken six pieces per a day.
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
60 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria general elderly people
Key exclusion criteria 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
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Nishikawa
Organization Ehime University Graduate School of medicine
Division name Neurology and Clinical pharmacology
Zip code
Address 454 Shitsukawa Tohon Ehime
TEL 089-960-5095
Email n-nishi@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Nishikawa
Organization Ehime University Graduate School of medicine
Division name Neurology and Clinical pharmacology
Zip code
Address 454 Shitsukawa Tohon Ehime
TEL 089-960-5095
Homepage URL
Email n-nishi@m.ehime-u.ac.jp

Sponsor
Institute Ehime University Graduate School of medicine
Neurology and Clinical pharmacology
Institute
Department

Funding Source
Organization Kishu Hosokawa
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
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
2016 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 16 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 04 Month 10 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 15 Day
Last modified on
2017 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027219

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.