UMIN-CTR Clinical Trial

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
Institute	TTC Co., Ltd
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042962