UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011732 |
|---|---|
| Receipt number | R000013712 |
| Scientific Title | To administer the extract Salacia plant supplementation to Japanese adult male for 4 weeks for analyzing the effectiveness of the immune function and evaluate the effectiveness of an improvement in immune strength through this study.Study design: a double-blind placebo controlled trial. |
| Date of disclosure of the study information | 2013/09/12 |
| Last modified on | 2019/05/14 09:09:38 |
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Basic information
Public title
To administer the extract Salacia plant supplementation to Japanese adult male for 4 weeks for analyzing the effectiveness of the immune function and evaluate the effectiveness of an improvement in immune strength through this study.Study design: a double-blind placebo controlled trial.
Acronym
Effectiveness of an Improvement in Immune Strength by Taking the Extract Salacia Plant Supplementation for Evaluation.
Scientific Title
To administer the extract Salacia plant supplementation to Japanese adult male for 4 weeks for analyzing the effectiveness of the immune function and evaluate the effectiveness of an improvement in immune strength through this study.Study design: a double-blind placebo controlled trial.
Scientific Title:Acronym
Effectiveness of an Improvement in Immune Strength by Taking the Extract Salacia Plant Supplementation for Evaluation.
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To administer the extract Salacia plant supplementation to Japanese adult male for 4 weeks for analyzing the effectiveness of the immune function and evaluate the effectiveness of an improvement in immune strength through this study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
immune function
Key secondary outcomes
Intestinal microbiota analysis,Gene expression analysis,safety evaluation
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
Administer study drugs to subjects within 4 weeks.
Interventions/Control_2
Administer placebo to subjects within 4 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
| 50 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Japanese male who are equal or more than 50-year-old and less than 60-year-old when informed consent is obtained.
2) Subjects who get exhausted easily and cannot seem to shake the fatigue.
3) Subjects who go to the office on the day shift.
4) Subjects who live a well-regulated life rhythm.
Key exclusion criteria
1) Subjects who have present and/or past history of disease of heart, kidneys, liver and digestive system.
2) Exclusion disorders: atrial fibrillation, arrhythmia, hepatic disease (especially who have present and/or past history of disease of hepatitis), kidney disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases.
3) Subjects who contract a disease related to digestive (e.g. obstipation and to have loose bowel).
4) Subjects who have serious anemia.
5) Subjects who regularly take supplementation and medicines included herbal one.
6) Subjects who have allergy to the medicine and food related to this study.
7) Subjects who regularly take food and drug of the effect of calming intestinal disorders within a month.
8) Subjects who drink excessive amounts of alcohol.
9) Smokers.
10) Diabetes.
11) Subjects who are participating in other clinical trials, either participated within 3 months.
12) Subjects who are not considered eligible to participated in this study by medical doctor or the study center.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
1050013
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | MASUDA |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
1050013
Address
3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
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
Shiba Palace Clinic
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
| 2013 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
-
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0142909
Number of participants that the trial has enrolled
32
Results
-
Results date posted
| 2019 | Year | 05 | Month | 13 | Day |
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
| 2013 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 29 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 12 | Day |
Last modified on
| 2019 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013712
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