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The efficacy and safety of Ninjin'yoeito for anorexia, apathy in dementia.

A randomized controlled trial of efficacy and safety of Ninjin'yoeito for anorexia, apathy in dementia. - Nanthy Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200079
Enrollment
120
Registered
2020-08-07
Start date
2020-08-07
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

Anorexia in dementia with apathy Dementia/Anorexia/Apathy

Interventions

Ninjin'yoeito administered three times daily (3.0 g each, 9.0 g / day) during the 12-week treatment period.

Sponsors

Arai Tetsuaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Alzheimer type dementia, Dementia with Lewy Bodies or Dementia associated with Parkinson's disease 2. MMSE less than 23 3. Neuropsychiatric Inventory subcategory scores for apathy 1 point or above 4. Neuropsychiatric Inventory subquestion scores for a loss of appetite 3 points or above 5. Treatment has been kept for psychotropic, antiulcer, estrogen, ACEI and zinc compound 6. Treatment has been kept for donepezil, galantamine, rivastigmine, memantine, antipsychotic, antiparkinson and steroid. 7. Agreement to sign an informed consent from patient, legal representative, study partner. Have a study partner able to provide an independent evaluation of functioning 8. Location; outpatient, inpatient, has been kept. 9. A patient who is able to take oral medications. 10. A patient who was informed dementia.

Exclusion criteria

Exclusion criteria: 1) Complications that may affect cognitive function. 2) Severe agitation/aggression 3) Major depression or bipolar disorder within the previous a year. Alcoholism within the previous 2 years, history of drug addiction, Vitamin B12 deficiency, folate deficiency, syphilis or thyroid disorders. 4) Digestive disorders 5) Patients with a life-threatening disease such as malignant tumor 6) Use of prohibited medication (prokinetic agent, stomachics and digestives, some kampo) within the previous 4 weeks 7) Participation in other studies within the previous 12 weeks. 8) Allergic to kampo 9) Pseudohyperaldosteronism 10) Potassium value is less than 3.0mEq / L 11) A patient who is not able to take kampo because of dysphagia. 12) Remarkable hypertension, edema 13) Heart failure, Kidney failure, Decompensated cirrhosis 14) A patient who takes glycyrrhizin

Design outcomes

Primary

MeasureTime frame
Anorexia at 12 weeks compared to baseline (NPI score)

Secondary

MeasureTime frame
Total score of NPI Subscale of NPI Food intake Vitality Index MMSE,FAB Weight, Anemia, CONUT, Albumin

Contacts

Public ContactMasashi Tamura

University of Tsukuba Hospital

mtamura@md.tsukuba.ac.jp+81-29-853-3178

Outcome results

None listed

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