Frailty or prefrailty.
Conditions
Interventions
TSUMURA Goshajinkigan Extract Granules, 7.5g per day, 24 weeks
Sponsors
Hagihara Keisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who meet a criterion for frailty or pre-frailty by J-CHS. 2) Patients with low muscle strength(hand grip strength: less than 26 kg for men and 18 kg for women) or low physical performance (below normal gait speed 1m/s) 3) Patients who are 65 years old or older at the time of informed consent and do not received certification of needed support or needed long-term care. 4) Patients who can go to hospital for outpatient. 5) Patients who can take Kampo medicine preparations orally. 6) Patients who obtained written consent for this study.
Exclusion criteria
Exclusion criteria: 1)Patients who took Kampo medicine preparation within 4 weeks from the start of treatment. 2)Patients who have allergic episode with Kampo medicine preparations in the past. 3)Patients with obvious joint deformities due to rheumatoid arthritis etc. 4)Patients who has serious complicated disease (disease such as liver, kidney, heart, lung, blood, metabolic, or malignant tumor). 5)Patients who have embedded medical devices such as cardiac pacemakers. 6)Patients suspected of having dementia (MMSE score 23 or below). 7)Patients who are participating in or are planning to participate in clinical trials or other clinical studies. 8)Patients who are considered ineligible to participate by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Changes in : hand grip strength, two- step test, six-minute walk test. 2)Changes in : physical activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Changes in: soft lean mass, skeletal muscle mass index/SMI, body weight, fat mass (body fat mass/percent body fat), extracellular water ratio, extracellular water, phase angle, BMI 2)Changes in: toe gap force, gait speed 3)Changes in: sleep analysis parameters(sleep onset latency: SOL, nocturnal total sleep time: NTST, wake time after sleep onset and number of awakening: WASO, sleep efficiency: SE, average wake time, total physical activity 4)Changes in: Jinkyo score 5)Changes in: scores of Resilience scale 6)Changes in: scores of The Kihon Checklist 7)Changes in: Locomo-5-score 8)Changes in: scores of MMSE-J 9)Changes in: scores of Question about social connections 10)Changes in: scores of GDS-S-J15 11)Blood nutrition assessment: CONUT value (Alb, TLC/lymphocyte count, T-Cho) 12)Frequency of events related to frailty (fall, fracture, new Certification of Needed Support or Needed Long-Term Care, death) | — |
Contacts
Public ContactKeisuke Hagihara
Osaka University Graduate School of Medicine
Outcome results
None listed