UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048622 |
|---|---|
| Receipt number | R000042440 |
| Scientific Title | Clinical trial on the efficacy and safety for the dysuria of the mixture of Peucedanum japonicum, nobiletin and tomato lycopene |
| Date of disclosure of the study information | 2022/08/08 |
| Last modified on | 2022/08/08 15:47:21 |
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Basic information
Public title
Clinical trial on the efficacy and safety for the dysuria of the mixture of Peucedanum japonicum, nobiletin and tomato lycopene
Acronym
Clinical trial for the urination disorder of the mixture of Peucedanum japonicum, nobiletin and tomato lycopene
Scientific Title
Clinical trial on the efficacy and safety for the dysuria of the mixture of Peucedanum japonicum, nobiletin and tomato lycopene
Scientific Title:Acronym
Clinical trial for the urination disorder of the mixture of Peucedanum japonicum, nobiletin and tomato lycopene
Region
| Japan |
Condition
Condition
Urine storage disorder (urinary frequency, nocturia, urgency, urge incontinence)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of the peucedanum japonicum-nobiletin-tomato lycopene mixture for adult volunteers with urine storage disorders (urinary frequency, nocturia, urgency, urge incontinence).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total score for overactive bladder symptom score
Key secondary outcomes
Daytime urinary frequency, night urinary frequency, International prostate symptom score, QOL score
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
20 active lead groups and 20 placebo lead groups
Interventions/Control_2
After 3 weeks of administration, take 2 weeks off and cross over 3 weeks of administration
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women who have urinary frequency, nocturia, urgency, or urge incontinence for more than 2 months, and who have some trouble with it
Key exclusion criteria
1 micturition disorder in treatment
2 Within 2 months from the end of treatment for micturition disorder
3 have no sense of urination
4 dysuria is the main symptom
5 Communication of the will is difficult
6 Allergies to ingredients and drugs
7 Others that the doctor in charge judged that registration to this study was inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Southen Knights' Laboratory Co. Ltd.
Division name
Clinical department
Zip code
904-0113
Address
1-1-823 Miyagi, Chatan, Okinawa
TEL
090-4998-7459
sugaya@med.u-ryukyu.a.jp
Public contact
Name of contact person
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Southen Knights' Laboratory Co. Ltd.
Division name
Clinical department
Zip code
904-0113
Address
1-1-823 Miyagi, Chatan, Okinawa
TEL
090-4998-7459
Homepage URL
sugaya@med.u-ryukyu.a.jp
Sponsor or person
Institute
Southen Knights' Laboratory Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Okinawa Research Center 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
Kawahara urology clinic Ethics Review Board
Address
73-3 Nishimotida, Ara, Kagoshima
Tel
0995-64-5181
yamashita.hami@kawahara.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 | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Shinryo to Shinyaku, 2020; 57: 501-511
Publication of results
Published
Result
URL related to results and publications
Shinryo to Shinyaku, 2020; 57: 501-511
Number of participants that the trial has enrolled
40
Results
Shinryo to Shinyaku, 2020; 57: 501-511
Results date posted
| 2022 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Shinryo to Shinyaku, 2020; 57: 501-511
Participant flow
Shinryo to Shinyaku, 2020; 57: 501-511
Adverse events
Shinryo to Shinyaku, 2020; 57: 501-511
Outcome measures
Shinryo to Shinyaku, 2020; 57: 501-511
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 08 | Day |
Last modified on
| 2022 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042440
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
