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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000909
Receipt No. R000001096
Scientific Title Effects of traditional Chinese medicine for chorea in the Huntington's disease.
Date of disclosure of the study information 2008/05/16
Last modified on 2010/09/22

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Basic information
Public title Effects of traditional Chinese medicine for chorea in the Huntington's disease.
Acronym Traditional Chinese medicine for Huntington's disease
Scientific Title Effects of traditional Chinese medicine for chorea in the Huntington's disease.
Scientific Title:Acronym Traditional Chinese medicine for Huntington's disease
Region
Japan

Condition
Condition Huntington's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the effect of traditional Chinese medicines for the chorea in Huntington's disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Unified Huntington's Disease Rating Scale (UHDRS)
Key secondary outcomes Cognitive function, ADL, Use of rescue drug, toralance

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Step1 To take Chai hu jia long gu mu li tang 56 days
Step2 Wash out 28 days
Step3 To take Yigan San 56 days
Interventions/Control_2 Step1 To take Yigan San 56 days
Step2 Wash out 28 days
Step3 To take Chai hu jia long gu mu li tang 56 days
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
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Clinically diagnosed as Huntington's disease according to ICD10 with abnormal prolongation of CAG repeat in IT15 gene.
2.At least one subscore of UHDRS is more than 3.
3.Serum potassium level is within the normal limit.
4.Stayed in the hospital over 5 years
5.A single care giver takes care each patient.
Key exclusion criteria 1.with any malignancy
2.with severe heart disease, liver disease, blood disease, respiratory disease and any other severe diseases influenced on the patients states
3.With any neurodegenerating diseases other than Huntington's disease
4.Alcohol abuse, drug abuse, metabolic toxicity, chronic inflammatory diseases
5.Who can not take herbal medicine per os.
6.Who are perscribed any antipsychotics newly in the observation period.
7. Others who are judged as inadequate by attending doctors.
Target sample size 4

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koh Iwasaki
Organization Graduate School of Medicine, Tohoku University
Division name Center for Asian Traditional Medicine
Zip code
Address 1-1 Seiryo-cho, Aoba Ward, Sendai City Miyagi Japan
TEL 022-717-7182
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koh Iwasaki
Organization Graduate School of Medicine, Tohoku University
Division name Center for Asian Traditional Medicine
Zip code
Address 1-1 Seiryo-cho, Aoba Ward, Sendai City Miyagi Japan
TEL 022-717-7182
Homepage URL
Email QFG03604@nifty.com

Sponsor
Institute Yonezawa National Hospital
Institute
Department

Funding Source
Organization Yonezawa National Hospital.
Organization
Division
Category of Funding 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

Other administrative information
Date of disclosure of the study information
2008 Year 05 Month 16 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 Mov Disord. 2009 Feb 15;24(3):453-5.
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 Completed
Date of protocol fixation
2007 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
2008 Year 04 Month 01 Day
Date trial data considered complete
2008 Year 04 Month 01 Day
Date analysis concluded
2008 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 11 Month 27 Day
Last modified on
2010 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001096

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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