UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015209 |
|---|---|
| Receipt number | R000017597 |
| Scientific Title | To evaluate the anti-influenza effects of Grifola frondosa extracts using a double-blind, placebo-controlled study. |
| Date of disclosure of the study information | 2014/09/19 |
| Last modified on | 2017/06/15 13:55:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
To evaluate the anti-influenza effects of Grifola frondosa extracts using a double-blind, placebo-controlled study.
Acronym
Anti-influenza effects of Grifola frondosa extracts.
Scientific Title
To evaluate the anti-influenza effects of Grifola frondosa extracts using a double-blind, placebo-controlled study.
Scientific Title:Acronym
Anti-influenza effects of Grifola frondosa extracts.
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the immune function and antibody producing ability for influenza vaccines by continuous ingestion of 6.825g per day of dehydrated grifola frondosa extracts for 12 weeks and to investigate its efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Influenza antibody titer, Natural Killer cell activity
Key secondary outcomes
IgG, IgM, defferential leukocyte count, IL-12, VAS, frequency of appearance of cold-like symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Four week before inoculation of influenza vaccine and 8 weeks after inoculation, with daily ingestion of 20 pills of grifola frondosa extracts (6.825 g/day).
Interventions/Control_2
Four week before inoculation of influenza vaccine and 8 weeks after inoculation, with daily ingestion of 20 placebo pills per 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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who plan to get inoculated with influenza vaccine in the current financial year.
2. Subjects who show low NK cell activity
3. Subjects who agree to participate in the current study with written informed consent.
Key exclusion criteria
1. Subjects with serious diseases or infections such as cerebrovascular, cardiac, liver, kidney, gastrointestinal tract or condition which need immediate reporting to the authorities
2. Subjects who are suspected of acute infection morbidity from diseases such as influenza
3. Subjects who undergo treatment for chronic inflammatory diseases autoimmune diseases or allergies etc
4. Subjects who receive vaccination 12 weeks before participating in this study
5. Subjects who had been inoculated with influenza vaccine in past and showed anaphylaxis
6. Subjects who have a major surgical history such as gastrectomy, gastrointestinal suture surgery or intestinal resection etc
7. Subjects with frequent complaints of post-menopausal symptoms
8. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data
9. Subjects with serious anemia
10. Subjects with a history of allergy to medicine and food (especially mushroom, eggs, chicken meat)
11. Subjects who regularly undertake medication which can affect the immune function (antibiotics, immunosuppressive drugs, anti-inflammatory drugs, anti-rheumatic drugs, antihistamines, anti-allergy drugs, lactic acid bacteria supplements etc.) Chinese herbal medicine, health food, supplements, extracts from (mushroom, seaweed, nucleic acids, yeast, lactic acid bacteria etc)
12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle
13. Subjects who donate either 400ml whole blood within 12 weeks or plasma, platelets within 4 weeks or blood component within 2 weeks prior to this study
14. Subjects who are pregnant or under lactation or ones who would expect to be pregnant during the study
15. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial
16. Subjects who are ineligible due to physician's judgment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun Nishihira, M.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi Nopporo, Ebetsu, 069-8585, Hokkaido
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun Nishihira, M.D. |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, Nishi Nopporo, Ebetsu, 069-8585, Hokkaido
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries, Government of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Forest Products Research Institute, Forest Research Department, Local Independent Administrative Agency Hokkaido Research Organization
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 09 | Month | 19 | 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
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 22 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 19 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 19 | Day |
Last modified on
| 2017 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017597
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
