UMIN-CTR Clinical Trial

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
Last 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
1st 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
Institute	IMMUDYNE INC.
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041203