NIPH Clinical Trials Search

JRCT ID: jRCTs031200079

Registered date:07/08/2020

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedAnorexia in dementia with apathy
Date of first enrollment09/10/2020
Target sample size120
Countries of recruitment
Study typeInterventional
Intervention(s)Ninjin'yoeito administered three times daily (3.0 g each, 9.0 g / day) during the 12-week treatment period.


Primary OutcomeAnorexia at 12 weeks compared to baseline (NPI score)
Secondary OutcomeTotal 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 maximumNot applicable
Include criteria1. 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 criteria1) 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


Public contact
Name Masashi Tamura
Address 2-1-1 Amakubo,Tsukuba-City,Ibaragi,Japan Ibaraki Japan 305-8576
Telephone +81-29-853-3178
Affiliation University of Tsukuba Hospital
Scientific contact
Name Tetsuaki Arai
Address 2-1-1 Amakubo,Tsukuba-City,Ibaragi,Japan Ibaraki Japan 305-8576
Telephone +81-29-853-3178
Affiliation University of Tsukuba Hospital