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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030220
Receipt No. R000034521
Scientific Title The trial of comparison onthe effect of "MANYO-REISHI premium" on immune function and QOL -Randomized Control Trial-
Date of disclosure of the study information 2017/12/01
Last modified on 2018/05/23

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Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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