UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015208 |
|---|---|
| Receipt number | R000017563 |
| Scientific Title | Double-blind, placebo-controlled study to evaluate adjuvanticity effects of Pleurotus cornucopiae extracts. |
| Date of disclosure of the study information | 2014/09/19 |
| Last modified on | 2015/04/28 10:17:02 |
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Basic information
Public title
Double-blind, placebo-controlled study to evaluate adjuvanticity effects of Pleurotus cornucopiae extracts.
Acronym
Adjuvanticity effects of Pleurotus cornucopiae extracts.
Scientific Title
Double-blind, placebo-controlled study to evaluate adjuvanticity effects of Pleurotus cornucopiae extracts.
Scientific Title:Acronym
Adjuvanticity effects of Pleurotus cornucopiae extracts.
Region
| Japan |
Condition
Condition
immunodepletion
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the adjuvanticity of Pleurotus cornucopiae extract, 80mL daily ingestion for 8 weeks, and to prove its beneficial effects. Additionally to evaluate anti-stress, blood pressure lowering, blood sugar improving effects and to evaluate the overall health promotion and maintenance by Pleurotus cornucopiae extracts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Natural killer cell activity
Key secondary outcomes
Blood cortisol, IL-12, MIF, serum neopterin, blood pressure, fasting blood glucose, HbA1c, VAS questionnaire
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Pleurotus cornucopiae extracts 80mL per day for 8 weeks
Interventions/Control_2
Placebo 80 mL per day for 8 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who show low NK cell activity.
2. Subjects who agree to participate in the current study with written informed consent.
Key exclusion criteria
1. Subjects who are under medication for chronic ailments (especially diseases related to cancer, liver, kidney, heart, gastrointestinal tract, diabetes, hypertension, mental disorder etc)
2. Subjects with serious diseases or infections such as cerebrovascular, cardiac, liver, kidney, gastrointestinal tract or condition which need immediate reporting to the authorities
3. Subjects who are suspected of acute infection morbidity from diseases such as influenza
4. Subjects who undergo treatment for chronic inflammatory diseases autoimmune diseases or allergies etc
5. Subjects who receive vaccination 12 weeks before participating in this study or those who will get inoculated during this study period
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, soybean, wheat)
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
40
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, Hokkaido, 069-8585, Japan
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, Hokkaido, 069-8585, Japan
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
Three B Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
北海道情報大学 保健センター（北海道）
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 | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 10 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 19 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 19 | Day |
Last modified on
| 2015 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017563
