UMIN-CTR Clinical Trial

Public title

The trial of comparison onthe effect of "MANYO-REISHI premium" on immune function and QOL -Randomized Control Trial-

Acronym

"MANYO-REISHI premium" Trial

Scientific Title

The trial of comparison onthe effect of "MANYO-REISHI premium" on immune function and QOL -Randomized Control Trial-

Scientific Title:Acronym

"MANYO-REISHI premium" Trial

Region

Japan

Condition

Healthy Adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

VAS(visual analogue scale)of any symptoms of cold and tiredness.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	KAZUO TAKAYASU

Organization

AKIYAMA SANGYO Co.,Ltd.

Division name

Special Sales Division

Zip code

Address

Koamicho15-9, Nihonbashi, Chuo-ku, Tokyo

TEL

03-3668-0981

Email

takayasu@akiyamasangyo.com

Name of contact person

1st name
Middle name
Last name	KAZUO TAKAYASU

Organization

AKIYAMA SANGYO Co.,Ltd.

Division name

Special Sales Division

Zip code

Address

Koamicho15-9, Nihonbashi, Chuo-ku, Tokyo

TEL

03-3668-0981

Homepage URL

Email

takayasu@akiyamasangyo.com

Institute

CLINICAL CREATIVE CORPORATION

Institute

Department

Personal name

Organization

AKIYAMA SANGYO Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

10

Month

25

Day

Date of IRB

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

Other related information

Registered date

2017

Year

12

Month

01

Day

Last modified on

2018

Year

05

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034521