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

Arai Tetsuaki0 个研究点目标入组 120 人开始时间: 2020年8月7日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

•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

发起方

Arai Tetsuaki