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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001659
Receipt No. R000002000
Scientific Title Efficacy and safety of a traditional Chinese medicine yokukansan for chorea and psychosis in the Huntington's disease.
Date of disclosure of the study information 2009/08/01
Last modified on 2011/01/07

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Basic information
Public title Efficacy and safety of a traditional Chinese medicine yokukansan for chorea and psychosis in the Huntington's disease.
Acronym Traditional Chinese medicine for Huntington's disease
Scientific Title Efficacy and safety of a traditional Chinese medicine yokukansan for chorea and psychosis 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 efficacy and safety of a traditional Chinese medicine yokukansan for the chorea and psychosis in Huntington's disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

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

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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 Step1. Treated with yokukansan 12 weeks
Step2. Wash out 12 weeks
Interventions/Control_2 Step1. 12 weeks waiting period
Step2. Treated with yokukansan 12 weeks
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
20 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. The patients have symptoms agreed to use yokukansan with public medical insurance in Japan. It includes irritation, quick tempered, hypersensitivity and insomnia.
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 the herbal medicine.
6. Who are perscribed any antipsychotics newly in the observation period.
7. Others who are judged as inadequate by attending doctors.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Takeda
Organization Tohoku University Graduate school of medicine
Division name Department of Neurology
Zip code
Address 1-1 Seiryo-cho, Aoba Ward, Sendai City Miyagi Japan
TEL 022-717-7189
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koh Iwasaki
Organization Tohoku University Graduate school of medicine
Division name Center for Asian Traditional Medicine
Zip code
Address 1-1 Seiryo-cho, Aoba Ward, Sendai City Miyagi Japan
TEL 022-717-7185
Homepage URL
Email QFG03604@nifty.com

Sponsor
Institute Dept. Nerol and Center for traditional Asian medicine, Tohoku University Graduate school of medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology, Grant-in-aid scientific research (now in apply).
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Ntional hospital organization Yonezawa hospital
Nishitaga national hospital
Osaka prefectural hospital organization, medical center
National center of neurology and psychiatry
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
2009 Year 08 Month 01 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 Completed
Date of protocol fixation
2009 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
2010 Year 08 Month 01 Day
Date trial data considered complete
2010 Year 10 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 01 Month 26 Day
Last modified on
2011 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002000

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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