UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001659 |
|---|---|
| Receipt number | 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 13:09:05 |
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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
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
QFG03604@nifty.com
Sponsor or person
Institute
Dept. Nerol and Center for traditional Asian medicine, Tohoku University Graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002000
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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