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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012902
Receipt No. R000015076
Scientific Title A double-blind, placebo controlled, randomized trial to evaluate the efficacy of SE in post-stroke rehabilitation patients.
Date of disclosure of the study information 2014/01/27
Last modified on 2015/10/15

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Basic information
Public title A double-blind, placebo controlled, randomized trial to evaluate the efficacy of SE in post-stroke rehabilitation patients.
Acronym A double-blind, placebo controlled, randomized trial to evaluate the efficacy of SE in post-stroke rehabilitation patients.
Scientific Title A double-blind, placebo controlled, randomized trial to evaluate the efficacy of SE in post-stroke rehabilitation patients.
Scientific Title:Acronym A double-blind, placebo controlled, randomized trial to evaluate the efficacy of SE in post-stroke rehabilitation patients.
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of SE on the maintenance or hypertrophy of skeketal muscle mass in post-stroke rehabilitation patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Skeletal muscle mass (BIA, thigh muscle area by Computed tomography)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 SE(Extract of Citrus species)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Aged 50 or older
2. Primary disease is first ever stroke
3. Within two weeks after admission
4. SIAS Knee-Extension Test score is within 3
5. Patients who can ride normal wheelchair
Key exclusion criteria 1. Impossible to get informed concent by cognitive deficit
2. Impossible to be treated with exercise therapy due to complication or previous disease
3. Impossible to swallow experimental food
4. Patients who receive parenteral or enteral Nutrition
5. peel of citrus species supplementation
6. Patients who are judged inappropriate for the study by the physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunitsugu Kondo
Organization Tokyo Bay Rehabilitation Hospital
Division name Tokyo Bay Rehabilitation Hospital
Zip code
Address 4-1-1 Yatsu, Narashino-shi, Chiba
TEL 047-453-9000
Email k.kondo@wanreha.net

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Honaga
Organization Tokyo Bay Rehabilitation Hospital
Division name Rehabilitation Department
Zip code
Address 4-1-1 Yatsu, Narashino-shi, Chiba
TEL 047-453-9000
Homepage URL
Email rh_fortune@hotmail.com

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization Morinaga Milk Industry 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
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
2014 Year 01 Month 27 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
2013 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2016 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 20 Day
Last modified on
2015 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015076

Research Plan
Registered date File name
2020/12/30 S1 File Protocol in English and Japanese.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/12/30 S3 File-Data set.pdf


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