The improving effect of Go-sha-jinki-gan on frailty.

JRCT ID: jRCTs051190072

Registered date:07/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Frailty or prefrailty.
• Date of first enrollment: 07/11/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): TSUMURA Goshajinkigan Extract Granules, 7.5g per day, 24 weeks

Outcome(s)

Primary Outcome

1)Changes in : hand grip strength, two- step test, six-minute walk test.
2)Changes in : physical activity.

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hagihara Keisuke
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development