UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial for improving QOL (Quality of Life) of healthy adults with knee joint pain.
Title of the study (Brief title)	A randomized controlled trial for improving QOL (Quality of Life) of healthy adults with knee joint pain.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of paprika pigment extract on QOL concerning knee joint pain.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Questionnaires (JKOM) (0, 4, 8 week)
Key secondary outcomes	Serum hs-CRP, Serum IL-6, Serum TNF-alpha (0, 8 week)

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	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 8 weeks Test material: Soft capsule contained 20mg of paprika pigment extract 2 capsules per day
Interventions/Control_2	Duration: 12 weeks Test material: placebo soft capsule 2 capsules per 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	45 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	a) Healthy adults with knee joint pain. b) Males and females aged 45 to 69 years old.
Key exclusion criteria	a) Persons who have previous medical history of malignant tumor, or heart failure and/or myocardial infarction. b) Patients being treated for at least one of following diseases: atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and/or other chronic disease. c) Persons who take medicines, herbal medicines, or dietary supplements. d) Persons who are allergic to medicines or foods related to the test material of this trial. e) Smokers f) Pregnant women, lactating women, or women who plan to get pregnant during the trial period. g) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial h) Persons who often take Satsuma mandarin oranges (Citrus unshiu Marc.) and/or their processed foods. i) Persons judged not suitable to participate in this trial by physician.
Target sample size	92

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Address	3F Sophia 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 Sophia 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	RIKEN VITAMIN CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seisin-kai Medical Association Inc, Takara Medical 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） Seisin-kai Medical Association Inc, Takara Medical Clinic (Tokyo).

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 27 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2016 Year 04 Month 02 Day
Date of closure to data entry	2016 Year 04 Month 02 Day
Date trial data considered complete	2016 Year 05 Month 20 Day
Date analysis concluded	2016 Year 06 Month 30 Day

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

Management information
Registered date	2015 Year 11 Month 30 Day
Last modified on	2016 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023086