UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of efficacy of plant-derived product in female with voiding dysfunction.
Title of the study (Brief title)	A study of efficacy of plant-derived product in female with voiding dysfunction.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of plant-derived product in female with voiding dysfunction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bladder diary
Key secondary outcomes	OABSS,N-QOL,PSQI-j

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	plant-derived product 28g per day for 8 weeks
Interventions/Control_2	placebo-controlled food 28g per day for 8 weeks
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	80 years-old >
Gender	Female
Key inclusion criteria	Females who are age from 20 to 80.
Key exclusion criteria	1) LUTS/OAB patients or subjects who need to treatment of disease. 2) Subjects who have the habit of taking test food. 3) Subjects who have the habit of taking healthcare products. 4) Subjects who have a habit of binge drinking. 5) Patients who have serious disease or subjects who have serious disease history. 6) Subjects who take warfarin potassium or antacid. 7) Subjects who has allergies to plants. 8) Urinary calculus or bladder calculus. 9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination. 10) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period. 11) Subjects who are participated in other clinical studies. 12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. 13) Subjects who are judged unfit to enroll in this trial by the investigator.
Target sample size	84

Research contact person
Name of lead principal investigator	Kenji Matsu
Organization	Marukai Corporation
Division name	None
Address	18-5, 1-chome, Kyomachibori, Nishi-ku, OSAKA, 550-0003 JAPAN
TEL	06-6443-0073
Email	kenji_matsu@marukai.co.jp

Public contact
Name of contact person	Hiroko Kageyama
Organization	Marukai Corporation
Division name	Sale dept.
Address	18-5, 1-chome, Kyomachibori, Nishi-ku, OSAKA, 550-0003 JAPAN
TEL	06-6443-0073
Homepage URL
Email	hiroko_kageyama@marukai.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2019 Year 02 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 09 Day
Anticipated trial start date	2017 Year 03 Month 22 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	2017 Year 03 Month 17 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030539