UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023634
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

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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 or person

Institute

Ehime University Graduate School of medicine
Neurology and Clinical pharmacology

Institute

Department

Personal name



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

Value
https://center6.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