The efficacy and safety of hachimijiogan for mild Alzheimer's disease

JRCT ID: jRCTs071190018

Registered date:02/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: mild Alzheimer's disease
• Date of first enrollment: 22/08/2019
• Target sample size: 86
• Study type: Interventional
• Intervention(s): One group will take hachimijiogan powder 7.5g/day for 6 months along with their previous standard treatment.The other group will continue the previous standard treatment for 6 months.

Outcome(s)

• Primary Outcome: ADAS-Jcog

Secondary Outcome

IADL(Instrumental Activity of Daily Life)
Apathy scale
NPI(Nueropsychiatric Inventor)

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1) Age:>=50 to <85 years old
2) Mild Alzheimer's disease (MMSE>=21)
3) Using the same dose of Donepezil, Galantamine, or Rivastigmine for more than three months
4) Not taking Memantine
5) Written informed consent

Exclude criteria

1) Taking Kampo Medicine other than Hachimijiogam
2) Kidney disfunction (eGFR<30mL/min/1.73m2)
3) AST or ALT>100 IU/L
4) Change of drug dosage that could affect the progression cognitive function during the three months
5) Complication with gastric ulcer, bronchial asthma, or epilepsy.
6) Judged by doctors not to be suited for study, such as having serious complications.

Related Information

• Primary Sponsor: Kainuma Mosaburo