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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035619
Receipt No. 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 2019/05/23

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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
Email 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
Email sugaya@medu-ryukyu.ac.jp

Sponsor
Institute Southern Knights' Laboratory
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 21 Day
Date of IRB
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
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040577

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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