Efficacy of Ninjin'yoeito, a representative Kampo (Japanese herbal medicine) formula for dual deficiency of qi and blood, in oral frailty: Observational study

Efficacy of Ninjin'yoeito, a representative Kampo (Japanese herbal medicine) formula for dual deficiency of qi and blood, in oral frailty: Observational study - Efficacy of Ninjin'yoeito, a representative Kampo (Japanese herbal medicine) formula for dual deficiency of qi and blood, in oral frailty: Observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039882

Enrollment

Registered

2020-03-19

Start date

2019-07-23

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

Oral frailty

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients having at least one indications for Ninjin'yoeito: Physical strength decline after illness or operation, fatigue/ malaise, loss of appetite, night sweat, coldness of hands and feet, or anemia. 2. Over 64 years old patients. 3. Outpatients with walking alone possibility. 4. Patients with oral frailty.

Exclusion criteria

Exclusion criteria: 1. Patients having taking Kampo formula with supplemental effect in the post 2 weeks. 2. Smoker in the post 1 year. 3. Patients having past history or suspicion of aldosteronism, myopathy, or hypokalemia. 4. Patients diagnosed as having the following: severe heart disease, kidney disease, or endocrine metabolic disease. 5. Patients considered inappropriate for this trial by the physicians-in-charge.

Design outcomes

Primary

Measure	Time frame
Score of subjective symptoms in questionnaire	—

Secondary

Measure	Time frame
1. Severity score of symptoms: Physical strength decline after illness or operation, fatigue/ malaise, loss of appetite, night sweat, coldness of hands and feet, or anemia. 2. Moitening of oral mucosa 3. RSST (Repetitive saliva swallowing test) 4. VAS (Visual Analogue Scale) of taste 5. Peripheral blood flow and blood flow velocity 6. Function of NK (Natural Killer) cell	—

Countries

Japan

Contacts

Public ContactAkiko Shirai

Kanazawa University Hospital Department of Otolaryngology, Head and Neck Surgery

shiraiaki@med.kanazawa-u.ac.jp076-265-2413

Outcome results