UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030857 |
|---|---|
| Receipt number | R000033932 |
| Scientific Title | Exploratory study on effectiveness and safety of long-term administration of Rikkunshito for improvement of anorexia and quality of life in patients with Parkinson's disease accompanied by apathy. |
| Date of disclosure of the study information | 2018/01/17 |
| Last modified on | 2019/07/30 18:58:08 |
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Basic information
Public title
Exploratory study on effectiveness and safety of long-term administration of Rikkunshito for improvement of anorexia and quality of life in patients with Parkinson's disease accompanied by apathy.
Acronym
Exploratory study on effectiveness and safety of long-term administration of Rikkunshito for improvement of anorexia and quality of life in patients with Parkinson's disease accompanied by apathy.
Scientific Title
Exploratory study on effectiveness and safety of long-term administration of Rikkunshito for improvement of anorexia and quality of life in patients with Parkinson's disease accompanied by apathy.
Scientific Title:Acronym
Exploratory study on effectiveness and safety of long-term administration of Rikkunshito for improvement of anorexia and quality of life in patients with Parkinson's disease accompanied by apathy.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Gastroenterology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the purpose of objective evaluation of anorexia and improvement of QOL of patients with Parkinson's disease accompanied by apathy, we conducted an open label study on the effectiveness (anorexia, quality of life, activity level etc.) and safety at the time of long-term administration of Rokkunshito We will conduct exploratory comparison studies between deformed concurrent groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) CNAQ
2) VAS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Parkinson's disease normal treatment + Rikkunshito treatment group
In addition to the usual treatment of Parkinson 's disease, Rikkunshito 6 months combined use
Interventions/Control_2
Parkinson's disease treatment group
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who satisfy all of the following items are targeted.
(1) Patients diagnosed with Parkinson's disease
(2) Hoehn-Yahr Classification I to III patients (conducted within 6 months)
(3) Patients with CNAQ of 28 or less
(4) Patients with a motivation score of 16 or more
(5) Age: 50 years old and over 90 years old
(6) Medical examination classification: outpatient
(7) Patients who obtain document consent from the principal
However, (3) (4) is conducted twice at intervals of 4 weeks. (3) are patients who satisfy the criteria in both cases, (4) subjects who meet the criteria twice and whose difference in score is within 5 points.
Key exclusion criteria
Patients applicable to any one of the following items are excluded.
(1) Patients complicated of dementia (patients with MoCA-J of 25 or less)
(2) Patients with depression, psychiatric symptoms
(3) Patients with abnormalities judged to require treatment by brain MRI (performed within 6 months)
(4) Patients who can not orally administer
(5) Patients who took herbal medicine within the first month before the start of the study
(6) Patients who can not discontinue combination use prohibited medicine during the observation period from two weeks before the start of the study
(7) Patients complicated of serious complications (heart, liver, kidney function disorder, hematopoietic disorder, malignant tumor etc.) or other diseases judged to affect life
(8) Patients allergic to traditional Chinese medicine
(9) Patients judged unsuitable by research researcher or research sharing doctor
However, MoCA-J of (1) is carried out twice at intervals of 4 weeks, and patients who were 25 points or less at once are excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Yakabi |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-8550
Address
1981, Kamoda, Kawagoe-shi, Saitama 350-8550 JAPAN
TEL
049-228-3598
kjyakabi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Yakabi |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-8550
Address
1981, Kamoda, Kawagoe-shi, Saitama 350-8550 JAPAN
TEL
049-228-3598
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 Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Saitama Medical University Hospital, Saitama Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee
Address
1981, Kamoda, Kawagoe-shi, Saitama 350-8550 JAPAN
Tel
049-229-3400
kjyakabi@saitama-med.ac.jp
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
埼玉医科大学病院、埼玉医科大学総合医療センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 17 | 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
| 2017 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 01 | Month | 17 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033932
