UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036216 |
|---|---|
| Receipt number | R000041256 |
| Scientific Title | The efficacy evaluation of the dietary supplement (composite material) on the low back pain and physical |
| Date of disclosure of the study information | 2019/03/17 |
| Last modified on | 2019/09/17 09:26:56 |
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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
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
k.isobe@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041256
