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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021101
Receipt No. R000024342
Scientific Title Effect of supplement containing lutein on knee joint symptoms. -a randomized, double blind, placebo-controlled study-
Date of disclosure of the study information 2016/08/31
Last modified on 2016/08/19

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Basic information
Public title Effect of supplement containing lutein on knee joint symptoms. -a randomized, double blind, placebo-controlled study-
Acronym Effect of supplement containing lutein on knee joint symptoms.
Scientific Title Effect of supplement containing lutein on knee joint symptoms. -a randomized, double blind, placebo-controlled study-
Scientific Title:Acronym Effect of supplement containing lutein on knee joint symptoms.
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate the effect of ingestion of supplement containing lutein on knee joint subjective symptoms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes JKOM and Knee Society Score(ver 2011)
Key secondary outcomes

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 Ingestion of supplement containing, lutein, salmon nasal cartilage extract (containing proteoglycan and type 2 collagen) and N-acetyl glucosamine for 12 weeks
Interventions/Control_2 Ingestion of placebo without lutein, salmon nasal cartilage extract (containing proteoglycan and type 2 collagen) and N-acetyl glucosamine for 12 weeks
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
30 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) Males and females aged from 30 to 74 years
2) Healthy subjects who feel pain of knee
3) Subject who is diagnosed KLgrade 0 or 1
4) Subject's score in the "pain, walking ability" of the JOA decision is less than 26 points
Key exclusion criteria 1) Subjects receiving treatment for pain of knee
2) Subjects receiving drug treatment
3) Subject receiving treatment for hyperuricemia
4) Subject receiving treatment or having a medical history for serious disease such as diabetes, cardiovascular disease, liver disease, kidney disease and heart disease
5) Subjects having rheumatism
6) Subjects having surgery of the knee or those who need knee surgery
7) Subjects having drug treatment plan for joint, during the test period
8) Subjects who has carried out the intra-articular injection of hyaluronic acid within two weeks, or the intra-articular injection of steroids within three months prior to the start of the present study
9) Subject having a medical history for disease related to bone and joints, such as fracture or sprain within three months
10) Subject taking lutein, salmon cartilage extract, proteoglycan, type 2 collagen, N-acetyl glucosamine, and other health food (hyaluronic acid, glucosamine, chondroitin sulfate, etc.) that might affect the evaluation of the test
11) Subject taking pharmaceutical products(especially glucosamine, chondroitin sulfate, vitamin D, containing amino acid, the drug treatment of osteoporosis)
12) Subject using a cane, routinely
13) Subject taking warfarin
14) Subject presenting known allergy to food or drug
15) For female subject: pregnancy or breast feeding, or possibility of pregnancy, or intention to be pregnant during the study
16) Subject deemed unsuitable by the investigator or test sharing doctor
Target sample size 88

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Yamato
Organization Medical Corporation Kouwakai Kouwa Clinic
Division name Director
Zip code
Address 6-33-17, komagome, toshima-ku, Tokyo, Japan
TEL 03-3917-8105
Email kouwa.clinic@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Toshiki Kataoka
Organization HUMA R&D CORP
Division name Business Promotion Division
Zip code
Address RBM hamamatsucho Bld, 9F, 1-27-12, Hamamatsucho, Minato-ku, Tokyo, Japan
TEL 03-3431-1260
Homepage URL
Email kataoka@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization FANCL Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 医療法人社団幸和会 幸和クリニック
(Medical Corporation Kouwakai Kouwa Clinic)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 31 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
2016 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 19 Day
Last modified on
2016 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024342

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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