The effectiveness of hochuekkito on the physical strength in hip fracture patients

JRCT ID: jRCTs071180027

Registered date:01/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hip fracture
• Date of first enrollment: 02/08/2017
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Rehabilitation alone
Rehabilitation + TSUMURA Hochuekkito extract granules for ethical use

Outcome(s)

• Primary Outcome: Physical strength (Physical activity and motivation)

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include 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 administration of investigational drugs
8) Inpatients
9) Patients who are able to give written informed consent

Exclude criteria

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

Related Information

• Primary Sponsor: Watanabe Mitsunobu
• Source(s) of Monetary Support: Pharmaceutical company Tsumura and Co.
• Secondary ID(s): UMIN000027244