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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033138
Receipt No. R000037737
Scientific Title Evaluation of the effectiveness of intake of proteoglycan-containing salmon nasal cartilage extracts on arthralgia, cartilage metabolism marker and bone metabolism marker of patients with knee joint pain for 12 weeks.
Date of disclosure of the study information 2018/06/25
Last modified on 2018/06/25

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Basic information
Public title Evaluation of the effectiveness of intake of proteoglycan-containing salmon nasal cartilage extracts on arthralgia, cartilage metabolism marker and bone metabolism marker of patients with knee joint pain for 12 weeks.
Acronym Efficacy evaluation of proteoglycan on knee joints pain
Scientific Title Evaluation of the effectiveness of intake of proteoglycan-containing salmon nasal cartilage extracts on arthralgia, cartilage metabolism marker and bone metabolism marker of patients with knee joint pain for 12 weeks.
Scientific Title:Acronym Efficacy evaluation of proteoglycan on knee joints pain
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of proteoglycan on knee joints discomfort.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japanese Knee Osteoarthritis Measure (JKOM), Japanese Orthopaedic Association score (JOA score)
Key secondary outcomes Visual Analogue Scale(VAS), C2C, CPII, HA, CTX-II, NTx
Hematologic test, Biochemistry test, Urinalysis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Proteoglycan capsules are ingested for 12 consecutive weeks at 10mg.
Interventions/Control_2
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Males and females at the ages of 40 to 85
2) Subjects who are classified into 0-III grade on the basis of the Kellgren-Lawrence classification. (Mainly grade 0 to II)
Key exclusion criteria 1) Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability
2) Subjects who are suspected gouty attack with hyperuricemia
3) Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain
4) Subjects who have performed arthroplasty or need it
5) Subjects who regularly take health food containing proteoglycan or related to bone and joint wellness from two week before the screening test to the end of the study
6) Subjects who regularly take medicine, except in the case of permission to take anti-pain and anti-inflammatory drug by physician
7) Subjects who is taking medicine that affects cartilage or bone metabolism marker such as bisphosphonate, hormone therapy
8) Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within two week before the screening test
9) Subjects who regularly take medicine
10) Subjects who get an intense exercise to make excessive load on the joints
11) Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within three month before the screening test
12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
13) Subjects who are judged unsuitable from clinical examination before ingestion
14) Subjects who need to take warfarin during the study
15) Subjects who have possibility of allergy symptoms onset by the raw material in test diet
16) Subjects who intend to become pregnant or lactating
17) Subjects who intend to participate in study period
18) Subjects who are judged as unsuitable for this study by physician
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keita Watanabe
Organization Kitashinyokohama Orthopedic Surgery
Division name Surgery
Zip code
Address 1-2-3 Kitashinoyokohama, Kohoku ku Yokohama-shi, Kanagawa
TEL 045-533-2237
Email soyaku@kaiseikai-net.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nakagawa
Organization TTC Co., Ltd
Division name Clinical Research Planning Department
Zip code
Address 1-20-2 Ebisunishi, shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization ICHIMARU PHARCOS Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 25 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
2010 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 28 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
2018 Year 06 Month 25 Day
Last modified on
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037737

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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