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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000021801
Receipt No. R000019482
Scientific Title Study on efficacy and safety of Hochuekkito for the treatment of partial paralysis as a complication of cerebrovascular disorder
Date of disclosure of the study information 2016/04/06
Last modified on 2017/04/21

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Basic information
Public title Study on efficacy and safety of Hochuekkito for the treatment of partial paralysis as a complication of cerebrovascular disorder
Acronym Efficacy of Hochuekkito for "partial paralysis" in patients undergoing rehabilitation
Scientific Title Study on efficacy and safety of Hochuekkito for the treatment of partial paralysis as a complication of cerebrovascular disorder
Scientific Title:Acronym 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
1st name
Middle name
Last name Naoki Fukumura
Organization Tsuruoka Kyoritu Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code
Address 38 Simmeimae, Kamiyamazoe, Tsuruoka City, Japan
TEL 0235-78-7511
Email fukumuranaoki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Fukumura
Organization Tsuruoka Kyoritu Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019482

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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