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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030857
Receipt No. 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

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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
Email 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
Email kjyakabi@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033932

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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