UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Okinawa mozuku on Defecation
Title of the study (Brief title)	Effects of Okinawa mozuku on Defecation
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of bowel improvement effect of Okinawa Mosuku
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	stool frequency, stool form, volume of stool
Key secondary outcomes	LDL-Cho, HDL-Cho, Total-Cho, body weight, BMI

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Capsule containing Okinawa Mozuku(8cupsule/day, 8week)
Interventions/Control_2	Capsule not containing Okinawa Mozuku, plcebo(8cupsule/day, 8week)
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Age: 20-60, healthy men and women (2) Stool frequency: 2-4/week (3) Having defecation trouble (4) BMI: <30 (5) Not having IBS
Key exclusion criteria	(1)Person who has a history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, other severe disease. (2)Those who have had surgery on the gastrointestinal tract (3)those judged by the investigator as inappropriate
Target sample size	30

Research contact person
Name of lead principal investigator	Naoki Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	tterashima@miula.co.jp

Public contact
Name of contact person	Makoto Terashima
Organization	Oneness support Co., Ltd.
Division name	Clinical trial Division
Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-4801-8917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization	Okinawa TLO Co., Ltd.
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	2016 Year 12 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 14 Day
Anticipated trial start date	2017 Year 01 Month 10 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	2016 Year 12 Month 07 Day
Last modified on	2017 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028761