UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009873 |
|---|---|
| Receipt number | R000011566 |
| Scientific Title | Examination about the effectiveness of levocarnitine for lumbar canal stenosis having leg cramps |
| Date of disclosure of the study information | 2013/01/25 |
| Last modified on | 2019/01/22 11:01:28 |
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Basic information
Public title
Examination about the effectiveness of levocarnitine for lumbar canal stenosis having leg cramps
Acronym
Examination about the effectiveness of levocarnitine for lumbar canal stenosis having leg cramps
Scientific Title
Examination about the effectiveness of levocarnitine for lumbar canal stenosis having leg cramps
Scientific Title:Acronym
Examination about the effectiveness of levocarnitine for lumbar canal stenosis having leg cramps
Region
| Japan |
Condition
Condition
lumbar canal stenosis
Classification by specialty
| Orthopedics | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate improvement degree of the leg cramps symptom and the temperature change of lower limbs by the levocarnitine internal use
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement degree of the leg cramps symptom and the numbness of lower limbs
Temperature change of lower limbs (using thermography)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
internal use levocarnitine 300mg per day and follow up at least 2 months
Interventions/Control_2
internal use levocarnitine 900mg per day and follow up at least 2 months
Interventions/Control_3
internal use syakuyaku-kanzoto 2.5mg per day and follow up at least 2 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient of the lumbar canal stenosis having leg cramps
Key exclusion criteria
It depends on physician's dicision
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Hyoda |
Organization
Osaka medical college
Division name
Department of anesthesiology
Zip code
Address
2-7 daigaku-machi Takatsuki Osaka Japan
TEL
072-683-1221
a-hyoda@qg7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Hyoda |
Organization
Osaka medical college
Division name
Department of anesthesiology
Zip code
Address
2-7 daigaku-machi Takatsuki Osaka Japan
TEL
072-683-1221
Homepage URL
a-hyoda@qg7.so-net.ne.jp
Sponsor or person
Institute
Department of anesthesiology Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of anesthesiology Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2017 | 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
| 2013 | Year | 01 | Month | 25 | Day |
Last modified on
| 2019 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011566
