UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019111 |
|---|---|
| Receipt number | R000022093 |
| Scientific Title | CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2015/10/05 09:28:56 |
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Basic information
Public title
CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking.
Acronym
The sarcopenia improvement effect by Abound (TM) drinking against ALS
Scientific Title
CaHMB L-arginine-glutamine blended drinks (Abound (TM)) for amyotrophic lateral sclerosis patients and sarcopenia improvement effect by drinking.
Scientific Title:Acronym
The sarcopenia improvement effect by Abound (TM) drinking against ALS
Region
| Japan |
Condition
Condition
Amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It will confirm the improvement effect of muscle mass loss due to intake of nutritious food for amyotrophic lateral sclerosis patients Abound(TM).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Improvement of muscle mass
2.Respiratory function test values, improvement of grip strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Abound(TM)
1,Take one pack twice a day in the moring and evening
2,Drinking was dissolved in water 240 ~ 300ml
3,Before meals, after meals does not matter
4,12 weeks
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.He was diagnosed with amyotrophic lateral sclerosis diagnostic criteria (El Escorial criteria revised version) in accordance amyotrophic lateral sclerosis, cases that have been made notice to the patient himself.
2.Patients that can be oral drinking
3.Patient consent is obtained in writing with respect to participation in the study.
Key exclusion criteria
1,Patients are managed breathing by the ventilator.
2,oral drinking difficult patient.
3,Patients with a history of side effects caused by Abound(TM).
4,Patients unable intention display in the self-
5,Patients who are judged to be inappropriate as a research subject.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyasu Kanai |
Organization
National Hospital Organization Takasaki General Medical Center
Division name
Division of Neurology
Zip code
Address
36 Takamatsucho, Takasaki-city, Gunma
TEL
027-322-5901
kanai@takasaki-hosp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuyasu Kanai |
Organization
National Hospital Organization Takasaki General Medical Center
Division name
Division of Neurology
Zip code
Address
36 Takamatsucho, Takasaki-city, Gunma
TEL
027-322-5901
Homepage URL
kanai@takasaki-hosp.jp
Sponsor or person
Institute
National Hospital Organization Takasaki General Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
独立行政法人国立病院機構 高崎総合医療センター（群馬県）/ National Hospital Organization Takasaki General Medical Center(Gunma)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 25 | Day |
Last modified on
| 2015 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022093
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
