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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026596
Receipt No. R000030539
Scientific Title A study of efficacy of plant-derived product in female with voiding dysfunction.
Date of disclosure of the study information 2019/02/28
Last modified on 2017/11/30

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Basic information
Public title A study of efficacy of plant-derived product in female with voiding dysfunction.
Acronym A study of efficacy of plant-derived product in female with voiding dysfunction.
Scientific Title A study of efficacy of plant-derived product in female with voiding dysfunction.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kenji Matsu
Organization Marukai Corporation
Division name None
Zip code
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
1st name
Middle name
Last name Hiroko Kageyama
Organization Marukai Corporation
Division name Sale dept.
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2017 Year 03 Month 09 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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