UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027903 |
|---|---|
| Receipt number | R000031967 |
| Scientific Title | A verification study on improvement of problems with urination due to ingestion of the food containing saw palm extracts : a randomized double-blind, parallel-group, placebo-controlled study |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2018/01/30 13:02:58 |
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Basic information
Public title
A verification study on improvement of problems with urination due to ingestion of the food containing saw palm extracts : a randomized double-blind, parallel-group, placebo-controlled study
Acronym
A verification study on improvement of problems with urination due to ingestion of the food containing saw palm extracts
Scientific Title
A verification study on improvement of problems with urination due to ingestion of the food containing saw palm extracts : a randomized double-blind, parallel-group, placebo-controlled study
Scientific Title:Acronym
A verification study on improvement of problems with urination due to ingestion of the food containing saw palm extracts
Region
| Japan |
Condition
Condition
Healthy human
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of the test food on problems with urination
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
International Prostate Symptom Score (IPSS)
*Assess at 0, 4, 8 and 12 weeks after consuming
Key secondary outcomes
1. King' s Health Questionnaire (KHQ)
2. Overactive Bladder Symptom Score (OABSS)
3. Subjective symptoms
3-1. Visual Analogue Scale (VAS)
Pleasantness of waking, Sleep quality
3-2. Diary
A frequency of urination per day, A frequency of urination at night
3-3. Interview sheet
Time required for urination
*1,2 Assess at 0, 4, 8 and 12 weeks after consuming
*3-2 Keep it from a week before consuming to 12 weeks after consuming
*3-1,3-3 Assess at 0 and 12 weeks after consuming
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test material: Saw palmetto extracts containing capsule A
Dose: Take a capsule once a day
Administration: Swallow a capsule after breakfast with water or warm water (approximately 200 mL) without chewing
*If you forget ingestion of the test food, take it as soon as you remember within the day.
Interventions/Control_2
Duration: 12 weeks
Test material: Placebo
Dose: Take a capsule once a day
Administration: Swallow a capsule after breakfast with water or warm water (approximately 200 mL) without chewing
*If you forget ingestion of the test food, take it as soon as you remember within the day.
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
1. Japanese men who are 40 or more to less than 70 years old
2. Those who wake up for urination at least twice during nocturnal sleep
3. Those who have problems with urination, e.g. urinary urgency, frequent urination, and urinary incontinence
4. Those who are considered as appropriate for the study by the principal investigator
5. Those whose high-sensitivity PSA level is less than 3.0 ng/mL (40-65 years old) or less than 3.5 ng/ml (65-70 years old) at screening and examination before ingestion
6. Those who get less than 20 in score of IPSS at screening and examination before ingestion and do not need the treatment
7. If number of people who passed 6. exceed the sample size, select those who have relatively high score in IPSS
Key exclusion criteria
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Those who need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, overactive bladder and urolithiasis
4. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily
5. Currently taking medicines and/or herbal medicines
6. Those who are allergic to medicines and/or the test food related products
7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial
8. Others consider as inappropriate for this test by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
YAWATA CORPORATION
NIHON PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic
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
医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 23 | 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 | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | 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
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2018 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031967
