UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025554 |
|---|---|
| Receipt number | R000028942 |
| Scientific Title | Protective efficiency of propolis via oxidative stress regulation in locomotive syndrome. |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2019/03/31 23:11:34 |
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Basic information
Public title
Protective efficiency of propolis via oxidative stress regulation in locomotive syndrome.
Acronym
Efficiecy of propolis in locomotive syndrome.
Scientific Title
Protective efficiency of propolis via oxidative stress regulation in locomotive syndrome.
Scientific Title:Acronym
Efficiecy of propolis in locomotive syndrome.
Region
| Japan |
Condition
Condition
Locomotive Syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the preventive effects of propolis in locomotive syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
motor function
Key secondary outcomes
oxidative stress level
antioxidant capacity
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
propolis
Interventions/Control_2
Placebo
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Volunteer with low back or knee pain and gait instability caused by motor weakness
Key exclusion criteria
Volunteer with diseases including internal midicine, psychogenic disorders, neuromuscular diseases, postoperative state of orthopaedic surgery, allergy against wheat and honey.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Nojiri |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Orthopaedics Surgery
Zip code
Address
3-3-20 Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
hnojiri@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Koike |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Orthopaedics Surgery
Zip code
Address
3-3-20 Shinsuna, Koto-ku, Tokyo
TEL
03-5632-3111
Homepage URL
ortho-m.koike@juntendo.ac.jp
Sponsor or person
Institute
Department of Orthopaedics Surgery, Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Farm, 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
Address
Tel
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
順天堂東京江東高齢者医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028942
