UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035619 |
|---|---|
| Receipt number | R000040577 |
| Scientific Title | Clinical trials on efficacy and safety of 3 novel combinations of Nobiletin, Kaempferia parviflora and Peucedanum japonicum for urine storage disorder |
| Date of disclosure of the study information | 2019/01/22 |
| Last modified on | 2022/08/08 16:00:27 |
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Basic information
Public title
Clinical trials on efficacy and safety of 3 novel combinations of Nobiletin, Kaempferia parviflora and Peucedanum japonicum for urine storage disorder
Acronym
Clinical trials of Nobiletin, Kaempferia parviflora and Peucedanum japonicum for urine storage disorder
Scientific Title
Clinical trials on efficacy and safety of 3 novel combinations of Nobiletin, Kaempferia parviflora and Peucedanum japonicum for urine storage disorder
Scientific Title:Acronym
Clinical trials of Nobiletin, Kaempferia parviflora and Peucedanum japonicum for urine storage disorder
Region
| Japan |
Condition
Condition
Urine storage disorders (urinary frequency, nocturia, urinary urgency, urgency incontinence)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Adult volunteers with urine storage disorder (urinary frequency, nocturia, urinary urgency, urgency incontinence) are administered with 3 combination drugs such as Nobiletin, Kaempferia parviflora and Peucedanum japonicum, and the effectiveness is examined. In succession, the effectiveness and safety of 3 volumes of three drug combinations (3 volumes 3 mixture) for urine storage disorder are examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overactive bladder symptom score
Key secondary outcomes
International prostate symptom score and QOL score
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Using 600 mg of 3 capsules (600 mg of content: Nobiletin high purity (60%) Seikwasa extract, Novilex 55 mg + Kaempferia parviflora dry powder 388 mg + Peucedanum japonicum dry powder 100 mg + crystalline cellulose 30 mg / + glycerin fatty acid ester 18 mg + fine silicon dioxide 9 mg) . Administration is 3 capsules once a day for the first 3 weeks and 9 capsules once a day for the remaining 4 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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
urine storage disorders (urinary frequency, nocturia, urinary urgency, urgency incontinence) have been present for more than 2 months but untreated adults
Key exclusion criteria
1.Those who are being treated for dysuria
2.Within two months of termination of treatment of voiding disorder
3.Those with no urinary trust
4.Difficulty of urination is the main symptom
5.Those with difficult communication difficulties
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Kitakami Central Hospital. Department of Urology
Division name
Director
Zip code
904-0101
Address
631-9 Kamisedo, Chatan, Okinawa, 904-0101, Japan
TEL
098-936-5111
sugaya@medu-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Kitakami Central Hospital. Department of Urology
Division name
Director
Zip code
904-0101
Address
631-9 Kamisedo, Chatan, Okinawa, 904-0101, Japan
TEL
098-936-5111
Homepage URL
sugaya@medu-ryukyu.ac.jp
Sponsor or person
Institute
Southern Knights' Laboratory
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 Urological Clinic
Address
73-3 Nishimotida, Aira, Kagoshima, Japan
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
北上中央病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
Shinryo to Shinyaku, 2020; 57: 923-929
Publication of results
Published
Result
URL related to results and publications
Shinryo to Shinyaku, 2020; 57: 923-929
Number of participants that the trial has enrolled
20
Results
Shinryo to Shinyaku, 2020; 57: 923-929
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: 923-929
Participant flow
Shinryo to Shinyaku, 2020; 57: 923-929
Adverse events
Shinryo to Shinyaku, 2020; 57: 923-929
Outcome measures
Shinryo to Shinyaku, 2020; 57: 923-929
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 22 | 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=R000040577
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| Registered date | File name |
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