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

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 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


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

Value
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