UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Keita Watanabe
Organization	Kitashinyokohama Orthopedic Surgery
Division name	Surgery
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	Takashi Nakagawa
Organization	TTC Co., Ltd
Division name	Clinical Research Planning Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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