UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026460
Receipt number R000030192
Scientific Title A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain
Date of disclosure of the study information 2017/03/10
Last modified on 2019/01/28 18:28:20

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Basic information

Public title

A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain

Acronym

A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain

Scientific Title

A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain

Scientific Title:Acronym

A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pain

Region

Japan


Condition

Condition

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objectives of this study are to verify the efficacy and safety of INJUV ingestion in individuals with knee and low back pain.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Improvement of knee pain (motion range evaluation of knee joints, JCOM, WOMAC)(2W, 4W, 6W, 8W)
[2]Improvement of low back pain (JLEQ)(2W, 4W, 6W,8W)

Key secondary outcomes

[1]Improvement of QOL(Anti-Aging QOL Common Questionnaire)
[2]Improvement of inflammation(hs-CRP)
[3]Anti-glycation(Pentosidine)
[4]Safety(Blood biochemistry etc.)


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

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of the test product (8 weeks)

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

55 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

[1]Japanese males and females aged 55-69 years
[2]Healthy individuals not receiving any medical disease treatment
[3]Individuals with knee and/or low back pain in daily life
[4]Individuals voluntarily join the study with written informed consent
[5]Individuals who can visit study site and receive examinations on designated days
[6]Individuals judged appropriate to join this study by principal investigators

Key exclusion criteria

[1]Individuals receiving medical drugs for treatment of chronic diseases
[2]Individuals receiving outpatient care (except for bonesetters, chiropractors, massagers) for knee and/or low back pain
[3]Individuals with history of palliative therapy (hyaluronic acid, steroid injection, etc.) or surgical therapy (arthroscopic osteotomy, artificial joint, bolt fixation surgery, etc.)on knees and/or waist
[4]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders
[5]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc.
[6]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.)
[7]Individuals with history of gastrointestinal disorders except for appendicitis
[8]Individuals with inflammatory disorders such as chronic sinusitis, periodontal disease, bronchitis, etc.
[9]Individuals with >=30.0kg/m2 BMI
[10]Individuals donated blood >200ml in past 1 month or >400ml in past 3 months
[11]Individuals with serious anemia
[12]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs
[13]Individuals continually consumed health foods that may interfere the study results (especially glucosamine, chondroitin, etc.) in the past 3 months except for general nutritional supplements
[14]Individuals with alcohol intake exceeding 40mg/day,200mg/week as ethanol volume
[15]Smokers or ex-smokers within one year after quitting
[16]Individuals who may significantly change exercise habit or lifestyle during the study period
[17]Individuals participating or planning to join the other clinical investigations during the study period
[18]Pregnant or lactating women (expected, desired inclusive)
[19]Individual with potential conflict of interests
etc.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshikazu Yonei

Organization

Doshisha University

Division name

Graduate School of Life and Medical Sciences

Zip code


Address

1-3 Tatara Miyakodani Kyotanabe City Kyoto, 610-0394, Japan

TEL

0774-65-6394

Email

yyonei@mail.doshisha.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyasu Tamura

Organization

TES Holdings Co., Ltd.

Division name

Department of Clinical Trial

Zip code


Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL


Email

info@tes-h.co.jp


Sponsor or person

Institute

Anti-Aging Bank Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

LAIMU Corporation

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

2017 Year 03 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.toukastress.jp/webj/article/2018/GS17-30.pdf?20180331

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

2017 Year 02 Month 24 Day

Date of IRB


Anticipated trial start date

2017 Year 03 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

2017 Year 03 Month 08 Day

Last modified on

2019 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030192


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name