UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000016470
Receipt No. R000019129
Scientific Title The efficacy evaluation of proteoglycan on cartilage biomarkers in subjects with knee joints discomfort.
Date of disclosure of the study information 2016/10/31
Last modified on 2017/08/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The efficacy evaluation of proteoglycan on cartilage biomarkers in subjects with knee joints discomfort.
Acronym Efficacy evaluation of proteoglycan on knee joints discomfort.
Scientific Title The efficacy evaluation of proteoglycan on cartilage biomarkers in subjects with knee joints discomfort.
Scientific Title:Acronym Efficacy evaluation of proteoglycan on knee joints discomfort.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of proteoglycan on knee joints discomfort.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes C2C, PIICP, CTX-II, CTX-II/PIICP, C1,2C, CS846, COMP, C1,2C/PIICP
Key secondary outcomes Visual Analogue Scale (VAS), Japanese Knee Osteoarthritis Measure (JKOM), Japanese Orthopaedic Association score (JOA score)

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 NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Proteoglycan capsules are ingested for 16 consecutive weeks at 10mg.
Interventions/Control_2 Placebo capsules (no proteoglycan) are ingested for 16 consecutive 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
35 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Males and females at the ages of 35 to 75
2. Subjects who confirmed pain of knee joint by JKOM and VAS.
3. Subjects who are classified into 0-II grade on the basis of the Kellgren-Lawrence classification. (Subjects who undiagnosed with Knee Osteoarthritis by physician)
Key exclusion criteria 1. Subjects who exceeded the value of knee pain more than the sum VAS value of other joint pain
2. Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability
3. Subjects who are suspected gouty attack with hyperuricemia
4. Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain
5. Subjects who have performed arthroplasty or need it
6. Subjects who regularly take health food containing proteoglycan or related to bone and joint wellness from three month before the screening test to the end of the study
7. Subjects who regularly take medicine, except in the case of permission to take anti-pain and anti-inflammatory drug by physician
8. Subjects who take medicine more than three days a week or plan to do them in study period
9. Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
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 a year before the screening test
12. Subjects who get a diagnosis of malignancy, are under treatment for hypertension, cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease
13. Subjects who consume an excess amounts of alcohol
14. Subjects who have possibility of allergy symptoms onset by the raw material in test diet
15. Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
16. Subjects who take warfarin
17. Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period
18. Subjects who intend to become pregnant or lactating
19. Subjects who are judged as unsuitable for this study by physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kumie Ito
Organization Yaesu Sakura dori Clinic
Division name Internal Medicine
Zip code
Address 1-6-6 yaesu, chuo-ku, Tokyo
TEL 03-6214-1285
Email k-ito@y-sakuradoori.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 ttcpwr2001@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
2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5488639/pdf/etm-14-01-0115.pdf
Number of participants that the trial has enrolled
Results Evaluation of the effect of salmon nasal proteoglycan on biomarkers for cartilage metabolism in individuals with knee joint discomfort: A randomized double-blind placebo-controlled clinical study.

Abstract
A randomized double-blind placebo-controlled clinical trial was conducted to evaluate the chondroprotective action of salmon nasal cartilage proteoglycan on joint health. The effect of oral administration of proteoglycan (10 mg/day) on cartilage metabolism was evaluated in individuals with knee joint discomfort but without diagnosis of knee osteoarthritis. The average age of patients was 52.6 +/- 1.1 years old. The effect of proteoglycan was evaluated by analyzing markers for type II collagen degradation (C1,2C) and synthesis (PIICP), and the ratio of type II collagen degradation to synthesis. The results indicated that the change in C1,2C levels significantly differed in the proteoglycan group compared with the placebo group following 16 weeks intervention among subjects with high levels of knee pain and physical dysfunction (total score of Japan Knee Osteoarthritis Measure more than 41) and subjects with constant knee pain (both P<0.05). There was a greater increase in PIICP levels in the proteoglycan group than the placebo group following intervention, although this difference was not significant in both sets of patients. Thus, the C1,2C/PIICP ratios decreased in the proteoglycan group, whereas they slightly increased in the placebo group following the intervention. Furthermore, no test supplement-related adverse events were observed during the intervention. Therefore, oral administration of salmon nasal cartilage proteoglycan at a dose of 10 mg/day may exert a chondroprotective action in subjects with knee joint discomfort. This effect was achieved by improving cartilage metabolism (reducing type II collagen degradation and enhancing type II collagen synthesis), without causing apparent adverse effects.
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 01 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 08 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
2015 Year 02 Month 07 Day
Last modified on
2017 Year 08 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019129

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.