UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019995 |
|---|---|
| Receipt number | R000023086 |
| Scientific Title | A randomized controlled trial for improving QOL (Quality of Life) of healthy adults with knee joint pain. |
| Date of disclosure of the study information | 2016/11/30 |
| Last modified on | 2016/11/30 11:40:33 |
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Basic information
Public title
A randomized controlled trial for improving QOL (Quality of Life) of healthy adults with knee joint pain.
Acronym
A randomized controlled trial for improving QOL (Quality of Life) of healthy adults with knee joint pain.
Scientific Title
A randomized controlled trial for improving QOL (Quality of Life) of healthy adults with knee joint pain.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazuo YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
3F Sophia Ochanomizu, 2-4-3 Yushima, 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
3F Sophia Ochanomizu, 2-4-3 Yushima, 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
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)
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）
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023086
