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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027903
Receipt No. 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

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email

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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031967

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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