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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034660
Receipt No. R000039454
Scientific Title assessment for relieving the tension of sympathetic nerve system.
Date of disclosure of the study information 2018/10/26
Last modified on 2018/10/26

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Basic information
Public title assessment for relieving the tension of sympathetic nerve system.
Acronym Relief the tension of sympathetic nerve system.
Scientific Title assessment for relieving the tension of sympathetic nerve system.
Scientific Title:Acronym Relief the tension of sympathetic nerve system.
Region
Japan

Condition
Condition pain desease
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment for the effect of Shigyakusann
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes assey the RR-interval,hidrodsis of their pslm and Pleth Variability Index after 1 month medication
Key secondary outcomes

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
85 years-old >=
Gender Male and Female
Key inclusion criteria someone who comfom to Shigyakusann
Key exclusion criteria someone who don't comform to Shigyakusann
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name UEMURA SATOKO
Organization Saga University Hospital
Division name Pain Clinic & Palliative Care Medicine
Zip code
Address Sagashi nabeshima5-1-1
TEL 0952-34-2324
Email uemuras@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name UEMURA SATOKO
Organization Saga University Hospital
Division name Pain Clinic & Palliative Care Medicine
Zip code
Address Sagashi nabeshima5-1-1
TEL 0952-34-2324
Homepage URL
Email uemuras@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 10 Month 26 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Assey the RR-interval, sweat of their palm and pleth variability index and observe the alteration between before 1month after medication of Shigyakusann

Management information
Registered date
2018 Year 10 Month 26 Day
Last modified on
2018 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039454

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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