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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009873
Receipt No. 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

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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
Email 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
Email a-hyoda@qg7.so-net.ne.jp

Sponsor
Institute Department of anesthesiology Osaka Medical College
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011566

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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