UMIN-CTR Clinical Trial

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

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

TTC Co., Ltd.

Institute

Department

Personal name

Organization

ICHIMARU PHARCOS Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

06

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

06

Month

25

Day

Last modified on

2018

Year

06

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037737