UMIN-CTR Clinical Trial

Basic information
Public title	Clinical significance of salivary alpha-amylase activity in patients with Parkinson's disease
Acronym	Alpha-amylase activity in patients with Parkinson's disease
Scientific Title	Relation between salivary alpha-amylase and mental stress in patients with Parkinson's disease
Scientific Title:Acronym	Salivary alpha-amylase and mental stress in patients with Parkinson's disease
Region	Japan

Condition
Condition	Parkinson's desease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Although salivary alpha amylase has been reported to be associated with psychological stress in the general population, the details are unknown in patients with neurodegenerative diseases. In the present study, we examined the relation between salivary alpha amylase and psychological stress in patients with Parkinson's disease, which is frequently associated with sympathetic neuropathy.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation of Salivary Alpha-Amylase Activity and Numerical Rating Scale (NRS)
Key secondary outcomes	Correlation of salivary alpha-amylase activity with age and salivary alpha-amylase activity with orthostatic hypotension

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Parkinson's desease and nomal control
Key exclusion criteria	Unwillingness to participate in the study
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Yui Middle name Last name Mukaiyama
Organization	Tokushima National Hospital National Hospital Organization
Division name	Shikoku Neuromuscular Centre
Zip code	776-0031
Address	1354 Shikiji, Kamojima, Yoshinogawa, Tokushima
TEL	0883242161
Email	mukaiyama.yui.cr@mail.hosp.go.jp

Public contact
Name of contact person	1st name Yui Middle name Last name Mukaiyama
Organization	Tokushima National Hospital National Hospital Organization
Division name	Shikoku Neuromuscular Centre
Zip code	776-0031
Address	1354 Shikiji, Kamojima, Yoshinogawa, Tokushima
TEL	0883242161
Homepage URL
Email	mukaiyama.yui.cr@mail.hosp.go.jp

Sponsor
Institute	Department of Clinical Research, Tokushima National Hospital National Hospital Organization
Institute
Department

Funding Source
Organization	Department of Clinical Research, Tokushima National Hospital National Hospital Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokushima National Hospital National Hospital Organization
Address	1354 Shikiji, Kamojima, Yoshinogawa, Tokushima
Tel	0883-24-2161
Email	mukaiyama.yui.cr@mail.hosp.go.jp

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	2020 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	Open public recruiting
Date of protocol fixation	2019 Year 09 Month 19 Day
Date of IRB	2019 Year 09 Month 19 Day
Anticipated trial start date	2019 Year 09 Month 19 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Outpatients and Inpatients at Tokushima National Hospital

Management information
Registered date	2020 Year 09 Month 30 Day
Last modified on	2020 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047888

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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