UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009626 |
|---|---|
| Receipt number | R000011294 |
| Scientific Title | The evaluation of the efficacy and the safety of rikkunshito on anorexia in Parkinson's disease patients |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2018/02/06 13:24:42 |
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Basic information
Public title
The evaluation of the efficacy and the safety of rikkunshito on anorexia in Parkinson's disease patients
Acronym
The effect of rikkunshito on anorexia in Parkinson's disease patients
Scientific Title
The evaluation of the efficacy and the safety of rikkunshito on anorexia in Parkinson's disease patients
Scientific Title:Acronym
The effect of rikkunshito on anorexia in Parkinson's disease patients
Region
| Japan |
Condition
Condition
Parkinson's disease patients
Classification by specialty
| Gastroenterology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluate efficacy and safety of rikkunshito in Parkinson's disease 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 appetite before and after treatment of rikkunshito
Key secondary outcomes
Evaluation of gastrointestinal symptoms using Gastrointestinal Symptom Rating Scale
Patient satisfaction
Gastric emptying
Plasma ghrelin level
Safety of rikkunshito
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anti-Parkinson's disease drug plus rikkunshito
Interventions/Control_2
Anti-Parkinson's disease drug
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Selection criterion at enrollment
1)Hoehn-Yahr staging 1-3
2)patients who were diagnosed at having anorexia according to questionnaire
3)Outpatients
4)Agreement to sigh an informed consent
Key exclusion criteria
1)Patients for whom oral administration was impossible
2)Patients who received drugs prohibited for concomitant use 2 weeks before treatment of rikkunshito
3)Patients with serious complications(liver,kidney,heart,blood,or metabolic disorders)
4)Patients with a history of hypersensitivity to traditional Japanese medicine
5)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 | Koji Yakabi |
Organization
Saitama Medical Center,Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1981 Kamoda, Kawagoe,Saitama 350-8550,Japan
TEL
049-228-3741
kjyakabi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Yakabi |
Organization
Saitama Medical Center,Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1981 Kamoda, Kawagoe,Saitama 350-8550,Japan
TEL
049-228-3741
Homepage URL
kjyakabi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center,Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
TSUMURA and CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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 | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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
| 2012 | Year | 12 | Month | 25 | Day |
Last modified on
| 2018 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011294
