Efficacy and safety of a traditional Chinese medicine yokukansan for chorea and psychosis in the Huntington's disease.

UMIN ID: UMIN000001659

Registered date:01/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Huntington's disease
• Date of first enrollment: 2009/03/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Step1. Treated with yokukansan 12 weeks Step2. Wash out 12 weeks
Step1. 12 weeks waiting period Step2. Treated with yokukansan 12 weeks

Outcome(s)

• Primary Outcome: Unified Huntington's Disease Rating Scale (UHDRS) Neuropsychiatric Inventry(NPI)
• Secondary Outcome: Cognitive function, ADL, Use of rescue drug, toralance

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Dept. Nerol and Center for traditional Asian medicine, Tohoku University Graduate school of medicine
• Secondary Sponsor: Ntional hospital organization Yonezawa hospital Nishitaga national hospital Osaka prefectural hospital organization, medical center National center of neurology and psychiatry
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology, Grant-in-aid scientific research (now in apply).