UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021801 |
|---|---|
| Receipt number | 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 12:35:58 |
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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
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
fukumuranaoki@gmail.com
Sponsor or person
Institute
Department of Rehabilitation
Tsuruoka Kyoritu Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019482
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
