UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on efficacy and safety of Hochuekkito for the treatment of partial paralysis as a complication of cerebrovascular disorder
Title of the study (Brief title)	Efficacy of Hochuekkito for "partial paralysis" in patients undergoing rehabilitation
Region	Japan

Condition
Condition	Patients undergoing rehabilitation for partial paralysis as a complication of cerebrovascular disorder
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the efficacy of Hochuekkito tor decreased ADL due to partial paralysis in patients undergoing rehabilitation after cerebrovascular disorder, and to collect and evaluate safety information.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	FIM(Functional Independence Measure)
Key secondary outcomes	Alb,Body weight,BMI,%Ideal body weight,Lymphocyte number,Hb,CRP,Incidence rate of complication

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TSUMURA Hochuekkito Extract Granules for Ethical Use
Interventions/Control_2	control
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with partial paralysis as a complication of cerebrovascular disorder 2)Patients with Functional Independence Measur(FIM;foe ADL evaluation) score of 40 points or lower 3)Recovering patients who have started rehabilitation within 1 week 4)Patients with Alb of less than 3.5g/dL 5)Patients aged 50 years or older and younger than 80 years (when giving informed consent) 6)Patients who can take oral investigational drugs 7)Both males and females are eligible 8)Inpatients 9)Patients who are able to give written informed consent
Key exclusion criteria	Patients who have any of the following conditions: 1)Insufficient nutrition intake (less than 1,400kcal/day) 2)CRP of 10g/dL or more 3)Grade 2 or severer on the physical disability certificate or Grade 3 or severer certification of long-term care need since before the onset of cerebrovascular disorder 4)Use of any Kampo medicine within 4 weeks before study initiation 5)Serious comorbidities (e.g., hepatic, renal, cardiac, hematological, and metabolic diseases) 6)Any other condition assessed as inappropriate for study participation by the investigator or subinvestigator (hereinafter referred to as "investigators, etc.")
Target sample size	100

Research contact person
Name of lead principal investigator	Naoki Fukumura
Organization	Tsuruoka Kyoritu Rehabilitation Hospital
Division name	Department of Rehabilitation
Address	38 Simmeimae, Kamiyamazoe, Tsuruoka City, Japan
TEL	0235-78-7511
Email	fukumuranaoki@gmail.com

Public contact
Name of contact person	Naoki Fukumura
Organization	Tsuruoka Kyoritu Rehabilitation Hospital
Division name	Department of Rehabilitation
Address	38 Simmeimae, Kamiyamazoe, Tsuruoka City, Japan
TEL	0235-78-7511
Homepage URL
Email	fukumuranaoki@gmail.com

Sponsor
Institute	Department of Rehabilitation Tsuruoka Kyoritu Rehabilitation Hospital
Institute
Department

Funding Source
Organization	TSUMURA & Co.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	鶴岡協立リハビリテーション病院（山形県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 06 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 08 Month 31 Day
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded	2016 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 06 Day
Last modified on	2017 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019482