Clinical investigation of ninjin'yoeito for psychiatric symptoms and physical frailty among patients with mild cognitive impairment and Alzheimer's disease.

Clinical investigation of ninjin'yoeito for psychiatric symptoms and physical frailty among patients with mild cognitive impairment and Alzheimer's disease. - Effect of ninjin'yoeito among patients with mild cognitive impairment and Alzheimer's disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035047

Enrollment

Registered

2018-11-28

Start date

2018-04-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild cognitive impairment or Alzheimer&#39

Interventions

Kracie Ninjinyoeito Extract Granules, 7.5g per day, 12 weeks No treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who suffer from weakness, exhaustion, and/or anorexia. 2) Patients with apathy. 3) Patients who were diagnosed with mild cognitive impairment or early to moderate Alzheimer's disease based on the criteria of the NIA-AA. 4) Patients who have MMSE score of 11 points or more. 5) Patients who can walk without assistance. 6) Patients who have provided consent for participation by each subject and a family or caregiver. 7) Patients who can receive cooperation from family or caregiver.

Exclusion criteria

Exclusion criteria: 1) Patients who have been taken other kampo medicines in the past month. 2) Patients who have MMSE score of 10 points or less. 3) Patients who switched or newly started using anti-dementia medications within 3 months from the start of the survey. 4) Patients who have been taking sweetroot-containing drug and/or glycyrrhizinate-containing drug. 5) Patients who switched or newly started using antipsychotic medications within 3 months from the start of the survey. 6) Patients who have mental disorders caused by cerebrovascular disorders, head injuries, brain tumors, or encephalitis. 7) Patients whom investigators consider to be ineligible.

Design outcomes

Primary

Measure	Time frame
Psychiatric symptoms: the Neuropsychiatric Inventory at 12 weeks	—

Secondary

Measure	Time frame
12 weeks 1) Weight (Body mass index) 2) Nutritional status: Mini Nutritional Assessment-short form 3) Appetite: Simplified Nutritional Appetite Questionnaire 4) Physical performance: grip strength, timed Up and Go test 5) Body composition: Bioelectrical impedance analysis 6) Physical activities: International Physical Activity Questionnaire short version 7) Cognitive function: Mini Mental State Examination 8) Vitality: Vitality Index 9) Depressive mood: 15-Geriatric depression scale	—

Measure

Time frame

12 weeks 1) Weight (Body mass index) 2) Nutritional status: Mini Nutritional Assessment-short form 3) Appetite: Simplified Nutritional Appetite Questionnaire 4) Physical performance: grip strength, timed Up and Go test 5) Body composition: Bioelectrical impedance analysis 6) Physical activities: International Physical Activity Questionnaire short version 7) Cognitive function: Mini Mental State Examination 8) Vitality: Vitality Index 9) Depressive mood: 15-Geriatric depression scale

—

Countries

Japan

Contacts

Public ContactTakashi Sakurai

National Center Geriatrics and Gerontology Center for Comprehensive Care and Research on Memory Disorders

tsakurai@ncgg.go.jp0562-46-2311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Clinical investigation of ninjin&#39;yoeito for psychiatric symptoms and physical frailty among patients with mild cognitive impairment and Alzheimer&#39;s disease.