UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036172
Receipt number R000041203
Scientific Title Open test
Date of disclosure of the study information 2020/05/01
Last modified on 2019/03/12 14:48:06

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Basic information

Public title

Confirming the impact on the urination frequency of "Immudyne URINUE"

Acronym

Immudyne URINUE Human test

Scientific Title

Open test

Scientific Title:Acronym

Open test

Region

Japan


Condition

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The study was planned to confirm the effect on urination frequency by consuming Immudyne URINUE commercialized by Immudyne.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) Safety: physiological test, biochemical test, hematology test
2) Usefulness: frequency of urination

Key secondary outcomes



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

Prevention

Type of intervention

Food

Interventions/Control_1

Take Immudyne URINUE for 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)The person usually feeling that there is a lot of number of times of the urination and not taking one for treatment of a disease.
2)Applicants who voluntarily participate in clinical trials for men and women aged 20 and over and obtain written consent.
3)Those who can stop taking medicines and supplements that affect urination, health tea, etc. during the test period.
4)If you have not taken a supplement that is predicted to permanently affect urination within 1 month before the start of the study.
5)Those who can maintain a constant daily lifestyle during the examination period.

Key exclusion criteria

1)If you have a serious disease (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental disease.
2)Patients who have a history of urinary diseases and surgery.
3)If you have 4 ng/ml or more of PSA measured in the pre-screening test.
4)Those who can not maintain daily living habits due to large changes in diet and exercise.
5)shift work, late work.
6)Possible food allergies or drug allergies to test food.
7)If you wish to have a pregnant woman, a nursing woman and a pregnancy during the examination period.
8)Others who are ineligible for examination by the investigator.
9)participants in other clinical trials within the past 1 month.

Target sample size

7


Research contact person

Name of lead principal investigator

1st name Shinkichi
Middle name
Last name Honda

Organization

IMMUDYNE INC.

Division name

president

Zip code

107-0062

Address

Ohara Bldg. 6F, 5-7-17, Minami Aoyama, Minato-ku, Tokyo

TEL

03-5467-6284

Email

sh-honda@immudyne.co.jp


Public contact

Name of contact person

1st name EIICHIRO
Middle name
Last name YAGI

Organization

IMMUDYNE INC.

Division name

ACADEMIC AFFAIRS

Zip code

107-0062

Address

Ohara Bldg. 6F, 5-7-17, Minami Aoyama, Minato-ku, Tokyo

TEL

03-5467-6284

Homepage URL

https://www.immudyne.co.jp/

Email

e-yagi@immudyne.co.jp


Sponsor or person

Institute

IMMUDYNE INC.

Institute

Department

Personal name



Funding Source

Organization

Self-procurement

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

IMMUDYNE INC.

Address

Ohara Bldg. 6F, 5-7-17, Minami Aoyama, Minato-ku, Tokyo

Tel

03-5467-6284

Email

e-yagi@immudyne.co.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



Other administrative information

Date of disclosure of the study information

2020 Year 05 Month 01 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

2019 Year 03 Month 01 Day

Date of IRB

2019 Year 03 Month 07 Day

Anticipated trial start date

2019 Year 04 Month 13 Day

Last follow-up date

2019 Year 06 Month 08 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 03 Month 12 Day

Last modified on

2019 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041203


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name