UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041956 |
|---|---|
| Receipt number | R000047888 |
| Scientific Title | Relation between salivary alpha-amylase and mental stress in patients with Parkinson's disease |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2022/10/02 13:07:13 |
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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
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
mukaiyama.yui.cr@mail.hosp.go.jp
Sponsor or person
Institute
Department of Clinical Research, Tokushima National Hospital National Hospital Organization
Institute
Department
Personal name
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
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
255
Results
There was no difference in salivary alpha-amylase(sAA) levels between the Parkinson's disease (PD) and control groups, while subjective stress in the control group was higher than in the PD group. On the other hand, subjective stress in the control group was higher than that in the PD group. sAA reflected mental stress in PD, but was highly related to age, not mental stress, in healthy subjects.
Results date posted
| 2021 | Year | 10 | Month | 01 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to the impact of the infection situation, the study results have not yet been published.
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
| 2022 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047888
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
