Elderly dementia patients
Conditions
Interventions
Oral administration of rikkunshito (2.5g t.i.d) before meals for 8 weeks
Sponsors
Juntendo Tokyo Koto Geriatric Medical Center, Juntendo University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criterion at enrollment 1) Patients who were diagnosed as dementia according to DMS-IV-TR 2) Patients who were diagnosed as having anorexia according to NPI-NH and percentage of food consumed 3) hospitalized patients 4)clinical dementia rating(CDR)≤2 5) Patients for whom oral administration was possible 6)Agreement to sigh an informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders) 2) Patients with gastrectomy 3)Patients who need to take enteral nutrition 4) patients with a history of hypersensitivity to traditional Japanese medicine 5) Patients who received drugs prohibited for concomitant use within 2 weeks before treatment of rikkunshito 6) Patients under medical treatment of gastrointestinal disorders (peptic ulcer, gastrointestinal bleeding, mechanical ileus or gastrointestinal perforation) and cancer 7) Patients considered inappropriate by the study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of food intake before and after treatment of rikkunshito | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of psychological symptoms(NPI-NH), appetite level(NPI-NH), cognitive function(MMSE), activities of daily living(Barthel index), body weight and nutrition(geriatric nutritional risk index) Change of cerebral blood flow using SPECT Safety of rikkunshito | — |
Countries
Japan
Outcome results
None listed