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

JRCT ID: jRCTs031200079

Registered date:07/08/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Anorexia in dementia with apathy
• Date of first enrollment: 09/10/2020
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Ninjin'yoeito administered three times daily (3.0 g each, 9.0 g / day) during the 12-week treatment period.

Outcome(s)

• Primary Outcome: Anorexia at 12 weeks compared to baseline (NPI score)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 55age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Arai Tetsuaki
• Source(s) of Monetary Support: Tsumura & Co.