UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011753 |
|---|---|
| Receipt number | R000013746 |
| Scientific Title | Clinical Trial for Immunostimulating effect of Physta(R)/Eurycoma Longifolia Extract - A Randomized Controlled Trial. |
| Date of disclosure of the study information | 2013/09/13 |
| Last modified on | 2017/01/30 18:28:41 |
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Basic information
Public title
Clinical Trial for Immunostimulating effect of Physta(R)/Eurycoma Longifolia Extract - A Randomized Controlled Trial.
Acronym
Clinical Trial for Immunostimulating effect of Physta(R)/Eurycoma Longifolia Extract
Scientific Title
Clinical Trial for Immunostimulating effect of Physta(R)/Eurycoma Longifolia Extract - A Randomized Controlled Trial.
Scientific Title:Acronym
Clinical Trial for Immunostimulating effect of Physta(R)/Eurycoma Longifolia Extract
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether Tongkat Ali makes the following effects on:
a) improving the Scoring of Immunological Vigor, which is proposed as one of the indices expressing the comprehensive immunity.
b) decreasing the Immunological Age
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Scoring of Immunological Vigor
Immunological Parameters
Key secondary outcomes
Total testosterone, Free testosterone
Questionnaires (POMS, Likert)
Blood test
Urinary test
Physical examinations
Marketing 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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 4 weeks
Test material: Eurycoma Longifolia root extract.......200 mg/day
Once/day
Interventions/Control_2
Duration: 4 weeks
Test material: Rice powder.......200mg
Once/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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) Healthy adults, who feel fatigue daily
b) Persons whose ages are between 40 and 59 years old
c) Low immunity score (SIV less than 23) on visit 1's examination
Key exclusion criteria
a) Persons who have previous medical history of heart failure and cardiacinfarction
b) Patients being treated for arterial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, dyslipidemia, hypertension, and other chronic disease
c) Persons who takes medicines, herbal medicines, and dietary supplements within 30 days
d) Persons who has allergy
e) Pregnant women, lactating women, or women who want to get pregnant during the trial period
f) Pollinosis patients
g) Smokers
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
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO, Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko SUZUKI |
Organization
ORTHOMEDICO, Inc.
Division name
R&D department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO, Inc.
Institute
Department
Personal name
Funding Source
Organization
Biotropics Malaysia Berhad
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Malaysia
Other related organizations
Co-sponsor
Seishin-kai Medical Association Inc, Takara clinic.
Institute for Health & Life Science.
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
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
| 2013 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
George A, Suzuki N, Abas AB, Mohri K, Utsuyama M, Hirokawa K, Takara T. Immunomodulation in Middle-Aged Humans Via the Ingestion of Physta Standardized Root Water Extract of Eurycoma longifolia Jack-A Randomized, Double-Blind, Placebo-Controlled, Parallel Study. Phytother Res. 2016; 30(4): 627-35.
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
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 13 | Day |
Last modified on
| 2017 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013746
