UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A preliminary study on efficacy of bicarbonate bathing on bloodstream improvement and blood nitric oxide levels in healthy volunteers
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Misato Nakagawa
Organization	Hakata Clinic
Division name	Hakata Clinic
Address	6-18, Tenyamachi, Hakata-ku, Hakata-shi, Fukuoka 812-0025 Japan
TEL	092-283-7701
Email	hinako-uchimaru@lta-med.com

Public contact
Name of contact person	Yasunari Hiramatsu
Organization	EBC&M LLC
Division name	Project planning &Development department
Address	Cross Office Mita 9F 5-9-20, shiba, Minato-ku, Tokyo 108-0041 Japan
TEL	03-6465-3833
Homepage URL
Email	info@ebc-m.com

Sponsor
Institute	EBC&M LLC
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020182