UMIN-CTR Clinical Trial

Public title

A knee collagen support study

Acronym

A knee collagen support study

Scientific Title

A knee collagen support study

Scientific Title:Acronym

A knee collagen support study

Region

Japan

Condition

Heslthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

An objection of the study is to examine influences of a test food product on flexibility, discomfort, and mobility of knee joints after males and females aged over 40 and below 75, who feel discomfort in knee joints but do not undergo treatment in orthopedics, continuously take the test food product for 12 weeks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

JOA
JKOM
VAS
hs-CRP

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Continuous intake of the test food product for 12 weeks.

Interventions/Control_2

Continuous intake of the placebo food product 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

Age-lower limit

40

years-old

<=

Age-upper limit

74

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Japanese males and Japanese females aged over 40 and below 75.
2.Presence of discomfort in knee joints.
3.Grade 0 to I in categories K to L in the X-ray examination during selection.
4.Score of 25 or lower on the JOA evaluation of "pain and walking ability" during selection.

Key exclusion criteria

1.Currently seeing a doctor for treatment of a knee joint pain.
2.Currently in treatment with medication.
3.Diagnosed with Hyperuricemia with possible occurrence of a gout attack.
4.Diagnosed with severe disorders such as diabetes, a circulatory disease, a hepatic disease, a renal disease and a cardiac disease, or previous history of any of those.
5.Positive result in a rheumatoid factor test prior to the intake or a possibility of gaining a pain caused by rheumatism.
6.Prior history of a knee surgery or necessity of a knee surgery.
7.Plan to undergo medical treatment on knees during a study period.
8.Underwent a hyaluronic acid injection within two weeks before the selection or a steroid injection within three months before the selection.
9.Diagnosed with bone or joint-related diseases such as a fracture and a sprain within the past three months.
10.Regular intake of health food that contains hyaluronic acid, glucosamine, chondroitin sulfuric acid, quercetin glycoside, vitamin D, or an amino-acid drug, and the intention of consuming the health food during the study period.
11.Regular intake of a pharmaceutical product with an influence on the evaluation of the study (particularly, a pharmaceutical product that contains glucosamine, chondroitin sulfuric acid, vitamin D or an amino-acid drug, or a pharmaceutical product for treatment of osteoporosis).
12.Regular use of a cane.
13.Regular intake of warfarin (product names: Warfarin, Warin, Arefarin, Warfarin K, etc.).
14.Allergic reaction to a food product or a drug.
15.Having the potential to become pregnant during the study or currently pregnant (including a possibility of being pregnant) or nursing.
16.Determined by the investigator or the subinvestigator to be unsuitable for enrollment in this study.

Target sample size

66

Name of lead principal investigator

1st name
Middle name
Last name	Yoshitada Hira

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

RBM hamamatsucho Bldg.9F,1-27-12 Hamamatsucho,Minato-ku,Tokyo

TEL

03-3431-1260

Email

hira@huma-c.co.jp

Name of contact person

1st name
Middle name
Last name	Yoshitada Hira

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

RBM hamamatsucho Bldg.9F,1-27-12 Hamamatsucho,Minato-ku,Tokyo

TEL

03-3431-1260

Homepage URL

Email

hira@huma-c.co.jp

Institute

HUMA R&D CORP

Institute

Department

Personal name

Organization

Wellvenus Corp

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

医療法人社団幸和会　幸和クリニック(東京都)

Date of disclosure of the study information

2016

Year

08

Month

29

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

2016

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

08

Month

29

Day

Last follow-up date

2016

Year

11

Month

26

Day

Date of closure to data entry

Date trial data considered complete

2016

Year

12

Month

30

Day

Date analysis concluded

2017

Year

01

Month

31

Day

Other related information

Registered date

2016

Year

08

Month

29

Day

Last modified on

2018

Year

04

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027431