UMIN-CTR Clinical Trial

Basic information
Public title	QOL evaluation of plant extract for healthy women
Acronym	QOL evaluation of plant extract for healthy women
Scientific Title	QOL evaluation of plant extract for healthy women
Scientific Title:Acronym	QOL evaluation of plant extract for healthy women
Region	Japan

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

Objectives
Narrative objectives1	QOL evaluation of plant extract for healthy women
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overactive bladder questionnaire (OAB-q), Stress-related VAS, Health-related QOL
Key secondary outcomes	voiding diary, water intake test

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	intake plant extract food for 8 weeks
Interventions/Control_2	intake placebo-controlled food 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	70 years-old >
Gender	Female
Key inclusion criteria	Females aged from 20 to 69 years old. Subjects who have psychological stress.
Key exclusion criteria	1) Subjects with dysuria, or who are being treated for dysuria. 2) Subjects who have the habit of taking test food. 3) Subjects who have the habit of taking similar 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) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination. 9) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period. 10) Subjects who are participated in other clinical studies. 11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. 12) Subjects who are judged unfit to enroll in this trial by the investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Taro Middle name Last name Ueda
Organization	Kobayashi Pharmaceutical Co., Ltd.
Division name	Central R&D Laboratory
Zip code	567-0057
Address	1-30-3, Toyokawa, Ibaraki-ciy, OSAKA, JAPAN
TEL	090-8510-4389
Email	t.ueda@kobayashi.co.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Ito
Organization	Kobayashi Pharmaceutical Co., Ltd.
Division name	Central R&D Laboratory
Zip code	567-0057
Address	1-30-3, Toyokawa, Ibaraki-ciy, OSAKA, JAPAN
TEL	080-4752-5102
Homepage URL
Email	y.itou@kobayashi.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.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	2020 Year 12 Month 04 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	42
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	2019 Year 12 Month 12 Day
Date of IRB	2019 Year 12 Month 12 Day
Anticipated trial start date	2020 Year 01 Month 14 Day
Last follow-up date	2020 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Registered contents were corrected in accordance with IRB (date of approval, December 12, 2019).

Management information
Registered date	2020 Year 01 Month 08 Day
Last modified on	2020 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044556