UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022829 |
|---|---|
| Receipt number | R000026299 |
| Scientific Title | A study of efficacy of plant-derived product in female with voiding dysfunction. |
| Date of disclosure of the study information | 2017/12/31 |
| Last modified on | 2017/06/23 11:51:26 |
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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
OABSS
Key secondary outcomes
N-QOL, PSQI-j, Bladder diary
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
plant-derived product 100 mL per day for 12 weeks
Interventions/Control_2
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
15
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
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
hiroko_kageyama@marukai.co.jp
Sponsor or person
Institute
TTC Co.,Ltd
Institute
Department
Personal name
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
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
| 2017 | Year | 12 | Month | 31 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 24 | 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
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2017 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026299
