UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011198 |
|---|---|
| Receipt number | R000013122 |
| Scientific Title | The evaluation of the efficacy and the safety of rikkunshito on anorexia in elderly dementia patients |
| Date of disclosure of the study information | 2013/07/16 |
| Last modified on | 2013/07/16 14:41:30 |
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Basic information
Public title
The evaluation of the efficacy and the safety of rikkunshito on anorexia in elderly dementia patients
Acronym
The Effect of rikkunshito on anorexia in elderly dementia patients
Scientific Title
The evaluation of the efficacy and the safety of rikkunshito on anorexia in elderly dementia patients
Scientific Title:Acronym
The Effect of rikkunshito on anorexia in elderly dementia patients
Region
| Japan |
Condition
Condition
Elderly dementia patients
Classification by specialty
| Gastroenterology | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of rikkunshito in elderly dementia patients with anorexia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of food intake before and after treatment of rikkunshito
Key secondary outcomes
Evaluation of psychological symptoms(NPI-NH), appetite level(NPI-NH), cognitive function(MMSE), activities of daily living(Barthel index), body weight and nutrition(geriatric nutritional risk index)
Change of cerebral blood flow using SPECT
Safety of rikkunshito
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
| Medicine |
Interventions/Control_1
Oral administration of rikkunshito
(2.5g t.i.d) before meals for 8 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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Selection criterion at enrollment
1) Patients who were diagnosed as dementia according to DMS-IV-TR
2) Patients who were diagnosed as having anorexia according to NPI-NH and percentage of food consumed
3) hospitalized patients
4)clinical dementia rating(CDR)≤2
5) Patients for whom oral administration was possible
6)Agreement to sigh an informed consent
Key exclusion criteria
1) Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders)
2) Patients with gastrectomy
3)Patients who need to take enteral nutrition
4) patients with a history of hypersensitivity to traditional Japanese medicine
5) Patients who received drugs prohibited for concomitant use within 2 weeks before treatment of rikkunshito
6) Patients under medical treatment of gastrointestinal disorders (peptic ulcer, gastrointestinal bleeding, mechanical ileus or gastrointestinal perforation) and cancer
7) Patients considered inappropriate by the study investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eizo Iseki |
Organization
Juntendo Tokyo Koto Geriatric Medical Center, Juntendo University School of Medicine
Division name
PET-CT Dementia Reseach Center
Zip code
Address
3-3-20 Shinsuna, Koto-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo Tokyo Koto Geriatric Medical Center, Juntendo University School of Medicine
Division name
PET-CT Dementia Reseach Center
Zip code
Address
3-3-20 Shinsuna, Koto-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Juntendo Tokyo Koto Geriatric Medical Center, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | 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
| 2013 | Year | 07 | Month | 16 | Day |
Last modified on
| 2013 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013122
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
