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
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
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
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
