UMIN-CTR Clinical Trial

Basic information
Public title	A Dose Finding Study on the Effect of Food Containing Plant Extract on Urinary Problems -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym	A Dose Finding Study on the Effect of Food Containing Plant Extract on Urinary Problems
Scientific Title	A Dose Finding Study on the Effect of Food Containing Plant Extract on Urinary Problems -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym	A Dose Finding Study on the Effect of Food Containing Plant Extract on Urinary Problems
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of food containing plant extract on urinary problems.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Indexes on urination
Key secondary outcomes	Indexes on sleeping Questionnaire

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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Food containing low-dose plant extract, 8 weeks consumption
Interventions/Control_2	Food containing high-dose plant extract, 8 weeks consumption
Interventions/Control_3	Food not containing plant extract, 8 weeks consumption
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Healthy Japanese males and females aged 20 to 79 years-old. 2)Subjects who tend to feel frequent urination and sleep trouble. 3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	1)Subjects who are currently visiting the hospital or have a current diseases. 2)Subjects who are suspected of having overactive bladder in the OABSS score. 3)Subjects who are suspected of having benign prostatic hyperplasia. 4)Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. 5)Subjects who use habitually medications. 6)Subjects who can't stop using medications, supplements and/or functional foods affecting urination or sleeping during test periods. 7)Subjects who are shiftworker, midnight worker and/or hard worker. 8)Subjects who have excessive alcohol. 9)Subjects who are pregnant or planning to become pregnant or breastfeed during the study period. 10) Subjects who live with people requiring long-term care 11)Subjects who have declared allergic reaction to ingredients contained in test foods. 12) Subjects who are participating in or willing to participate in other clinical studies. 13) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Naohiro Middle name Last name Nomura
Organization	Sokujinkai Kitahiroshima Hospital
Division name	Internal Medicine
Zip code	061-1121
Address	6-2-2 Central, Kitahiroshima City, Hokkaido
TEL	011-373-5811
Email	kanribukeiri@sokujinkai.or.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Nakahara
Organization	Clinical Creative Co.,Ltd.
Division name	Pharmaceutical Development Division
Zip code	061-1121
Address	6-1-3 Central, Kitahiroshima City, Hokkaido Japan
TEL	090-3203-4054
Homepage URL
Email	m-nakahara@cli-creative.com

Sponsor
Institute	Clinical Creative Co.,Ltd
Institute
Department

Funding Source
Organization	TOYO SHINYAKU Co., Ltd.
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	Sokujinkai Kitahiroshima Hospital
Address	6-2-2 Central, Kitahiroshima City, Hokkaido
Tel	011-373-5811
Email	kanribukeiri@sokujinkai.or.jp

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	2022 Year 04 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	Preinitiation
Date of protocol fixation	2022 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date	2022 Year 04 Month 08 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 07 Day
Last modified on	2022 Year 04 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054090