UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037671
Receipt number R000042962
Scientific Title The efficacy evaluation of the dietary supplement on discomfort, bending and stretching of the low back
Date of disclosure of the study information 2019/08/18
Last modified on 2020/10/12 15:33:15

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Basic information

Public title

The efficacy evaluation of the dietary supplement on discomfort, bending and stretching of the low back

Acronym

The efficacy evaluation of the dietary supplement on discomfort, bending and stretching of the low back

Scientific Title

The efficacy evaluation of the dietary supplement on discomfort, bending and stretching of the low back

Scientific Title:Acronym

The efficacy evaluation of the dietary supplement on discomfort, bending and stretching of the low back

Region

Japan


Condition

Condition

None

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of ingestion of the dietary supplement containing proteoglycan for 12 weeks on discomfort, bending and stretching of the low back

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

JLEQ

Key secondary outcomes

QOL questionnaire
Low back range of motion
Trunk muscle strength


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of test food containing proteoglycan for 12 weeks

Interventions/Control_2

Ingestion of placebo food 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



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Males and females aged 40 and over
(2) Subjects who have continuous low back discomfort for 3 months or more
(3) Subjects who have habit of sleeping on bedding alone
(4) Subjects with narrow values on low back range of motion

Key exclusion criteria

Subjects
(1) who have low back pain due to pain in other joints
(2) who are suspected gouty attack with hyperuricemia
(3) who have positive rheumatoid factors on the screening test or may have rheumatic pain
(4) who have performed arthroplasty on the low back or need it
(5) who regularly take health food which may affect joints or muscles
(6) who take medicine regularly
(7) who have been performed nerve block injection within a year before the screening test or need to be done in the study period
(8) who get an intense exercise to make excessive load on the body
(9) who have a history of disorders affecting the evaluation of effectiveness such as fracture of the low back and acute low back pain within a year before the screening test
(10) who regularly use a cane, a supporter of the low back or a corset
(11) who periodically conduct actions that may affect the evaluation of effectiveness
(12) who are under treatment of diseases that may affect the evaluation of effectiveness
(13) who have severe diseases or have a history of such serious disorders
(14) who are under treatment or have a history of mental diseases
(15) who have unsteady lifestyle or who work manual labor
(16) who drink a lot
(17) who have possibilities for emerging allergy onset related to the study
(18) who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(19) who have participated in other clinical study within a month before the screening test or who intend to participate in the study period
(20) who are in a pregnancy or lactation period in the study period
(21) who are judged as unsuitable due to lifestyle questionnaire
(22) who regularly smoke
(23) who are judged as unsuitable for the study by investigator for other reasons

Target sample size

54


Research contact person

Name of lead principal investigator

1st name Yukihiro
Middle name
Last name Takase

Organization

DyDo DRINCO, INC.

Division name

Healthcare Business Department

Zip code

530-0005

Address

2-7, Nakanoshima 2-chome, Kita-ku, Osaka, Japan

TEL

06-6222-2600

Email

takase@dydo.co.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Nakagawa

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

t.nakagawa@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

DyDo DRINCO, INC.

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

Aisei Hospital Ueno Clinic Research Ethics Committee

Address

2-18-6, Higashiueno, Taitou-ku, Tokyo

Tel

03-6455-0880

Email

t.saito@ttc-smo.jp


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

2019 Year 08 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

54

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

2019 Year 06 Month 27 Day

Date of IRB

2019 Year 06 Month 27 Day

Anticipated trial start date

2019 Year 08 Month 19 Day

Last follow-up date

2019 Year 12 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 13 Day

Last modified on

2020 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042962


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name