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Recruitment status Completed
Unique ID issued by UMIN UMIN000011753
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO, Inc.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013746


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