UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026720
Receipt No. R000030673
Scientific Title Effect of Kampo-medicine on autonomic nerve indices analyzed with head up-tilt test
Date of disclosure of the study information 2017/03/27
Last modified on 2017/10/09

* 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 Effect of Kampo-medicine on autonomic nerve indices analyzed with head up-tilt test
Acronym Kampo-medicine and autonomic nerve
Scientific Title Effect of Kampo-medicine on autonomic nerve indices analyzed with head up-tilt test
Scientific Title:Acronym Kampo-medicine and autonomic nerve
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the effect of Kampo-medicine on autonomic function test
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Change autonomic function data at 30 min after taking Kampo-medicine
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Kampo-medicine (Kakkon-to)
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
59 years-old >=
Gender Male and Female
Key inclusion criteria volunteer
Key exclusion criteria persons in therapy, pregnancy, bowel disturbance, autonomic dysfunction, hypertension, cardiac disease and any other healthy problems.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Nagai
Organization Shimane University Faculty of Medicine
Division name Laboratory Medicine
Zip code
Address 89-1 Enya-cho, Izumo city
TEL 0853-20-2409
Email anagai@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Nagai
Organization Shimane University Faculty of Medicine
Division name Laboratory Medicine
Zip code
Address 89-1 Enya-cho, Izumo city
TEL 0853-20-2409
Homepage URL
Email anagai@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 島根大学病院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 27 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
Date of protocol fixation
2016 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 27 Day
Last modified on
2017 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030673

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.