UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The trial of comparison onthe effect of "MANYO-REISHI premium" on immune function and QOL -Randomized Control Trial-
Title of the study (Brief title)	"MANYO-REISHI premium" Trial
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect for immune function and QOL due to taking the supplement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS(visual analogue scale)of any symptoms of cold and tiredness.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Supplement(6 tablets a day)
Interventions/Control_2	Placebo supplement(6 tablets a 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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Japanese men and women aged 20 to 80 at the time of acquiring consent 2) Those who judged that a principal Investigator will meet this trial aim 3) Those who can take the test supplement for 3 months 4) If the subject are doing diet therapy or exercise therapy, those who do not change during the trial duration 5) Those who obtains written consent
Key exclusion criteria	1)Those who suffering from severe cerebrovascular disease, heart disease, liver disease, renal disease, gastrointestinal disease, infection requiring notification 2)Those who suspected of suffering from acute infection such as influenza 3)who are receiving treatment for autoimmune diseases, chronic inflammatory diseases, allergic diseases 4)Those who received vaccination within 12 weeks before ingestion, or those who wish to consume during the test period 5)Those who with a history of major operations in the digestive system such as gastrectomy, gastrointestinal suture, intestinal resection 6)Those who with significant changes in physical condition before and after menopause 7)Those who with significant abnormalities in blood pressure measurement and blood test 8)Those who with advanced anemia 9)Those who are likely to have allergic symptoms to drugs or foods(especially mushrooms, soybeans, wheat) 10)Those who take chinese herbs, health foods, supplements(mushrooms, seaweeds, nucleic acids, Yeast, lactic acid bacteria, etc)and a medice that affect immune function, regularly. The subject will be able to take these kinds of things, if a principal investigator will permit those items. the subject should write it down in detail on the subject diary. 11)Those who are extremely irregular in excessive smoking and alcohol consumers, and lifestyle habits such as meals and sleep 12)Those who donate 400 ml blood within 12 weeks, 200 ml blood within 4 weeks or ingredient donation within 2 weeks 13)Those who are pregnant, nursing or who want pregnancy during the exam 14)Those who are participating in other clinical trials, or participating within 1 month 15)Those who are judged unqualified as a subject by a principal investigator
Target sample size	40

Research contact person
Name of lead principal investigator	KAZUO TAKAYASU
Organization	AKIYAMA SANGYO Co.,Ltd.
Division name	Special Sales Division
Address	Koamicho15-9, Nihonbashi, Chuo-ku, Tokyo
TEL	03-3668-0981
Email	takayasu@akiyamasangyo.com

Public contact
Name of contact person	KAZUO TAKAYASU
Organization	AKIYAMA SANGYO Co.,Ltd.
Division name	Special Sales Division
Address	Koamicho15-9, Nihonbashi, Chuo-ku, Tokyo
TEL	03-3668-0981
Homepage URL
Email	takayasu@akiyamasangyo.com

Sponsor
Institute	CLINICAL CREATIVE CORPORATION
Institute
Department

Funding Source
Organization	AKIYAMA SANGYO Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 25 Day
Anticipated trial start date	2017 Year 11 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 01 Day
Last modified on	2018 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034521