UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000909
Receipt number 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 02:29:30

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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 or person

Institute

Yonezawa National Hospital

Institute

Department

Personal name



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

Value
https://center6.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