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The effectiveness and the safety of TJ-41 hochuekkito on improving physical strength in patients after hip fracture

The effectiveness and the safety of TJ-41 hochuekkito on improving physical strength in patients after hip fracture - The effectiveness of hochuekkito on the physical strength in hip fracture patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027244
Enrollment
40
Registered
2017-05-18
Start date
2017-05-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing rehabilitation after hipfracture

Interventions

Rehabilitation + TSUMURA Hochuekkito extract granules for ethical use (Hochuekkito grope) Rehabilitation alone (control group)

Sponsors

Konan hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients after operation for hip fracture (osteosynthesis or femoral head prosthetic replacement 2) Patients who planned or undergoing postoperative rehabilitation 3) Patients who had walking ability more than indoor self-supporting walking before the injury. 4) Patients who do not planned the treatment by low-intensity pulsed ultrasound (LIPUS) 5) Patients with mini mental state examination (MMSE) score of 10 or more 6) Patients aged 65 years or older (when giving informed consent) 7) Patients who can take oral administrationof investigational drugs 8) Inpatients 9) Patients who are able to give written informed consent

Exclusion criteria

Exclusion criteria: Patients who have any of the following conditions are excluded. 1) Patients with severe mental disorders 2) Patients with severe complications for liver disease, kidney disease, heart disease, blood disease, autoimmune disease or metabolic disease, etc 3) Patients with malignant tumors or rheumatoid arthritis 4) Patients undergoing dialysis 5) Patients who take concomitant medications or investigational drugs within 2 weeks before starting this study 6) Patients who have a history of allergies or side effects in kampo 7) Patients who judged inappropriate for participation by investigators because they have other conditions

Design outcomes

Primary

MeasureTime frame
Physical strength (Physical activity and motivation)

Secondary

MeasureTime frame
1) Fatigue: 5 step questionnaire 2) Activities of daily living: Functional Independence Measure (FIM) 3) QOL: EQ-5D-5L Japanese version 4) Appetite: daily caloric intake 5) Body weight 6) Nutrition: Prealbumin level 7) Rehabilitation progress 8) Complication incidence rate 9) Length of stay in hospital 10) Home return rate

Countries

Japan

Contacts

Public ContactMitsunobu Watanabe

Konan hospital Department of Rehabilitation

konan-hp@kyouninkai.jp096-375-1112

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026