Recovery stage stroke
Conditions
Interventions
Ninjin'yoeito administered two or three times daily (9.0 g/ day) during the 12-weeks treatment period.
Sponsors
Abo Masahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese people resident in Japan. 2) Patients diagnosed with stroke (except for Subarachnoid hemorrhage) from MRI or CT 3. Taking the onset date of the stroke to be Day 1 of onset, patients who be able to start administration of the study drug within the period of Days 22 to 56 of onset. 4) Revised version of the Ability for Basic Movement Scale II (ABMS II) more than 3. 5) Fugl-Meyer Assessment of the upper limb motor function is 10 to 56. 6) Patients who be going to undergo. hospitalization and rehabilitation for 3 months 7) Age: 50 or older, Gender: Male/Female 8) Modified Rankin Scale (mRS) score of 0 or 1 before onset of stroke. 9) Patients who, in the judgment of the study physician, do not have cognitive impairment that would interfere with the implementation of rehabilitation.
Exclusion criteria
Exclusion criteria: 1) Patients with concurrent psychiatric disease such as dementia, depression or schizophrenia. 2) Patients with diseases or symptoms that make it difficult to perform rehabilitation. 3) Patients with concurrent conditions for which movement is contraindicated (patients with severe heart disease, uncontrolled hypertension, recent pulmonary embolism or severe orthopedic disease) 4) Patients deemed inappropriate, such as tumor by the investigator or sub-investigator. 5) Patients with physical disabilities before onset of stroke. 6) Allergic to kampo. 7) Pseudohyperaldosteronism. 8) Potassium value is less than 3.0mEq / L. 9) Patients who is not able to take kampo because of dysphagia. 10) Participation in other studies within the previous 12 weeks. 11) Patients who have taken herbal medicine within 4 weeks prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-second chair stand test (CS-30) at 12 week after administration compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)-11) at 4 week, 8 week and 12 week after administration compared to baseline. 12)- 14) at 12 week after administration compared to baseline. 1) Functional Independence Measure (FIM) 2) Revised version of the Ability for Basic Movement Scale II (ABMS II) 3) Fugl meyer assessment (FMA) of the upper limb motor function 4) Grip strength on the unaffected side 5) Japanese version of Starkstein's Apathy Scale 6) Visual Analogue Scale (VAS) for fatigue 7) The World Health Organization-Five Well-Being Index (WHO-5) 8)Simplified Nutritional Appetite Questionnaire of the Japanese elderly (SNAQ-JE) 9) Meal amount 10) Step count 11) Amount of rehabilitation 12) Geriatric Nutrional Risk Index (GNRI), albumin, prealbumin 13) Brain-derived neurotrophic factor (BDNF) 14) Body composition | — |
Contacts
Public ContactMasahiro Abo
The Jikei University Hospital
Outcome results
None listed