UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Trial for Immunostimulating effect of Physta(R)/Eurycoma Longifolia Extract - A Randomized Controlled Trial.
Title of the study (Brief title)	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	Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
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	Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D department
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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