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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021989
Receipt No. R000025321
Official scientific title of the study A study for evaluating the immunostimulating effect -A Randomized, double-blind, placebo controlled trial.
Date of disclosure of the study information 2016/04/19
Last modified on 2017/03/02

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Basic information
Official scientific title of the study A study for evaluating the immunostimulating effect
-A Randomized, double-blind, placebo controlled trial.
Title of the study (Brief title) A study for evaluating the immunostimulating effect
Region
Japan

Condition
Condition Healthy adults who feel fatigue
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of test food on immune functions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Scoring of Immunological Vigor after 4 weeks of intervention
Key secondary outcomes Immunological parameters
Physical examinations
Urinary test
Blood test
Questionnaires (Likert)
:after 4 weeks of intervention

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 Test food
Duration: 4 weeks
Dose: daily recommended dose
Usage: intake at optional timing
Interventions/Control_2 Placebo food
Duration: 4 weeks
Dose : daily recommended dose
Usage: intake at optional timing
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

Not applicable
Gender Male and Female
Key inclusion criteria a) Healthy adults, who feel fatigue
b) Persons whose ages are 20 years or older
c) Low immunity score (scoring immunological vigor: between 13 and 23) on visit 1's examination
Key exclusion criteria a) Persons who have previous medical history of cancer, heart failure and cardiacinfarction
b) Patients being treated for arterial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, digestive system disorder, autoimmune disorder, dyslipidemia, hypertension, and other chronic disease
c) Persons who takes medicines, herbal medicines, and dietary supplements
d) Persons who take in foods with an influence on Primary outcomes to more than three times a week in large quantities
e) Persons who take in foods with an influence on intestinal regulation to more than three times a week in large quantities
f) Persons who has allergy
g) Pregnant women, lactating women, or women who want to get pregnant during the trial period
h) Persons who enrolled in the other clinical trials within last 3 months before the agreement for the participation to the trial
i) Persons who investigator judge not suitable to participate in the trial
Target sample size 40

Research contact person
Name of lead principal investigator Kazuo YAMAMOTO
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Address 3F Sofia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person Naoko SUZUKI
Organization ORTHOMEDICO, Inc.
Division name R&D Department
Address 3F Sofia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization Lotte Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai medical Association Inc, Takara clinic.
Name of secondary funder(s)

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 医療法人社団 盛心会 タカラクリニック(東京都)
Seishin-kai Medical Association Inc, Takara clinic(Tokyo)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 19 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 19 Day
Anticipated trial start date
2016 Year 04 Month 20 Day
Last follow-up date
2016 Year 08 Month 09 Day
Date of closure to data entry
2016 Year 08 Month 09 Day
Date trial data considered complete
2016 Year 09 Month 21 Day
Date analysis concluded
2016 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2016 Year 04 Month 19 Day
Last modified on
2017 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025321

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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