UMIN-CTR Clinical Trial

Public title

A verification study for the effects of consumption of the test food on the improvement of urination issues

Acronym

A verification study for the effects of consumption of the test food on the improvement of urination issues

Scientific Title

A verification study for the effects of consumption of the test food on the improvement of urination issues: A randomized, double-blind, placebo-controlled, parallel-group comparison trial

Scientific Title:Acronym

A verification study for the effects of consumption of the test food on the improvement of urination issues

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of the test food on urination issues

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The measured value of the score of physical limitations of King's Health Questionnaire (KHQ) at 12 weeks after consumption (12w)

Key secondary outcomes

1. The measured values of the score of physical limitations of KHQ at four and eight weeks after consumption (4w, 8w)

2. The amount of change of the score of physical limitations of KHQ between screening (before consumption; Scr) and 4w, 8w, or 12w

3. The measured values and amounts of changes from Scr of the following items at 4w, 8w, and 12w: Nocturia quality of life questionnaire (N-QOL) overall score, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) total score, Pittsburgh Sleep Quality Index (PSQI) global score, and each domain score of KHQ (general health, incontinence impact, role limitations, social limitations, personal limitations, emotional problems, sleep/energy disturbance, and severity measures)

4. Daily fluid intake, the frequency of urination during the awake period, and the frequency of urination during nocturnal sleep every week after the start of test-food consumption

5. The measured values of the scores of the questionnaire (each item of N-QOL, ICIQ-SF, PSQI, and KHQ) at 4w, 8w, and 12w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Capsule containing saw palmetto
Administration: Take one capsule per day before going to bed

*If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 12 weeks
Test food: Placebo
Administration: Take one capsule per day before going to bed

*If you forget to take 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1. Japanese

2. Female

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects who feel a decline in quality of life due to urination issues

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects whose score of Questionnaire C of OABSS is less than 2

8. Subjects whose scores of physical limitations of KHQ are relatively low

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who need the treatment for diseases related to urination such as the overactive bladder, urolithiasis, and ureteral polyp

5. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use

6. Subjects who are currently taking medications (including herbal medicines) and supplements

7. Subjects who are allergic to medicines and/or the test food-related products

8. Subjects who work late-night shift

9. Subjects who are pregnant, lactating, or planning to become pregnant

10. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial

11. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

52

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

NIHON PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2020

Year

12

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

56

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

Recruitment status

Completed

Date of protocol fixation

2020

Year

11

Month

25

Day

Date of IRB

2020

Year

11

Month

25

Day

Anticipated trial start date

2020

Year

12

Month

11

Day

Last follow-up date

2021

Year

05

Month

29

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

12

Month

10

Day

Last modified on

2023

Year

03

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048751