UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017441 |
|---|---|
| Receipt number | R000020182 |
| Scientific Title | A preliminary study on efficacy of bicarbonate bathing on bloodstream improvement and blood nitric oxide levels in healthy volunteers |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2016/06/06 14:49:48 |
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Basic information
Public title
A preliminary study on efficacy of bicarbonate bathing on bloodstream improvement and blood nitric oxide levels in healthy volunteers
Acronym
A preliminary study on efficacy of bicarbonate bathing
Scientific Title
A preliminary study on efficacy of bicarbonate bathing on bloodstream improvement and blood nitric oxide levels in healthy volunteers
Scientific Title:Acronym
A preliminary study on efficacy of bicarbonate bathing
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of bicarbonate bathing on bloodstream improvement and blood nitric oxide levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood nitric oxide levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
bathing at home 3days
tap waterbathing(39-40C) for 20 minutes
test day
tap waterbathing(39-40C) for 20 minutes
Interventions/Control_2
bathing at home 3days
tap waterbathing(39-40C) for 20 minutes
test day
bicarbonate bathing(39-40C) for 20 minutes
Interventions/Control_3
bathing at home 3days
bicarbonate bathing(39-40C) for 20 minutes
test day
tap waterbathing(39-40C) for 20 minutes
Interventions/Control_4
bathing at home 3days
bicarbonate bathing(39-40C) for 20 minutes
test day
bicarbonate bathing(39-40C) for 20 minutes
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
-40s woomen who have cold constitution
-BMI:18.5-25.0, height:150-170cm
-blood pressure:normal(140/90mmHg)
-Capable of giving informed consent
Key exclusion criteria
-Subject who are under treatment
or supervised by physician
-Subjects who are difficult to maintain the lifestyle
-Subjects who are pregnant or under lactation
-hyperhidrosis
-Subjects who are judged ineligible by our physician
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misato Nakagawa |
Organization
Hakata Clinic
Division name
Hakata Clinic
Zip code
Address
6-18, Tenyamachi, Hakata-ku, Hakata-shi, Fukuoka 812-0025 Japan
TEL
092-283-7701
hinako-uchimaru@lta-med.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunari Hiramatsu |
Organization
EBC&M LLC
Division name
Project planning &Development department
Zip code
Address
Cross Office Mita 9F 5-9-20, shiba, Minato-ku, Tokyo 108-0041 Japan
TEL
03-6465-3833
Homepage URL
info@ebc-m.com
Sponsor or person
Institute
EBC&M LLC
Institute
Department
Personal name
Funding Source
Organization
HOT ALBUM Tansansen Tablet, Inc.
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
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
| 2015 | Year | 05 | Month | 07 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 07 | Day |
Last modified on
| 2016 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020182
