UMIN-CTR Clinical Trial

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