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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011732
Receipt No. 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

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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
Email 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
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013712

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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