UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy evaluation of the dietary supplement (composite material) on the low back pain and physical
Acronym	The efficacy evaluation of the dietary supplement on the low back pain
Scientific Title	The efficacy evaluation of the dietary supplement (composite material) on the low back pain and physical
Scientific Title:Acronym	The efficacy evaluation of the dietary supplement on the low back pain
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of the dietary supplement on the low back pain and physical evaluation for 8 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	JLEQ Low back range of motion
Key secondary outcomes	Trunk muscle strength Core temperature VAS (Joint pain of knee, elbow, ankle, shoulder, neck, back and hip and finger)

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 for 8 weeks
Interventions/Control_2	Ingestion of placebo food for 8 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	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Males and females at the ages of 20 to 60 (2) Subjects who have continuous low back pain 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) which low back pain is weaker than 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 or need it (5) who regularly take health food which may affect this study from three month before the screening test to the end of the study (6) who regularly take medicine (7) who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test (8) who get an intense exercise to make excessive load on the body (9) who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test (10) who regularly use a cane, supporter or corset (11) who periodically conduct actions that may affect the evaluation of effectiveness (12) who have under treatment that may affect the evaluation of effectiveness (13) who have nervous system diseases or severe diseases such as, malignant tumors, diabetes, liver diseases, kidney diseases, heart diseases, etc. and have a history of serious disorder (14) who has under treatment or a history of mental diseases or is strongly suspected of mental diseases (15) who work night and day shift or who work manual labor (16) who drink alcohol in large quantities (17) who regularly smoke or who started smoking cessation one year before screening test (18) who have possibilities for emerging allergy onset related to the study (19) who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (20) who have participated in other clinical study within a month before the screening test or who intend to participate in study period (21) who intend to become pregnant or lactating (22) who are judged as unsuitable due to lifestyle questionnaire (23) who are judged as unsuitable for the study by investigator for other reasons
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yukie Middle name Last name Ito
Organization	Q'SAI CO., LTD.
Division name	Research and Development Department
Zip code	810-8606
Address	1-7-16 Kusagae, Chuo-ku, Fukuoka-shi, Japan
TEL	092-724-0855
Email	ito@kyusai.co.jp

Public contact
Name of contact person	1st name Kotoha Middle name Last name Isobe
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	k.isobe@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	Q'SAI CO., LTD.
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 Reserch Ethics Committee
Address	2-18-6 Higashiueno, Taito-ku, Tokyo, Japan
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 03 Month 17 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
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 02 Month 14 Day
Date of IRB	2019 Year 02 Month 14 Day
Anticipated trial start date	2019 Year 03 Month 18 Day
Last follow-up date	2019 Year 08 Month 03 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 03 Month 15 Day
Last modified on	2019 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041256