UMIN-CTR Clinical Trial

Public title

A study for the effect of Ninjin'yoeito, a Kampo medicine, on the postoperative course of elderly patients with proximal hip fractures

Acronym

A study for the effect of Ninjin'yoeito, a Kampo medicine, on the postoperative course of elderly patients with proximal hip fractures

Scientific Title

A study for the effect of Ninjin'yoeito, a Kampo medicine, on the postoperative course of elderly patients with proximal hip fractures

Scientific Title:Acronym

A study for the effect of Ninjin'yoeito, a Kampo medicine, on the postoperative course of elderly patients with proximal hip fractures

Region

Japan

Condition

Patients undergoing rehabilitation after proximal hip fracture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of Ninjin'yoeito on the postoperative course of elderly patients with proximal hip fractures

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Functional Independence Measure (FIM)

Key secondary outcomes

1) Weight loss rate
2) Nutritional indicators (serum albumin level, CONUT, GNRI, MNA-SF, dietary sufficiency rate)
3) Physical index (BMI,IBW)

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Pseudo-randomization

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ninjin'yoeito is administrated in patients with proximal hip fracture 4 weeks after surgery

Interventions/Control_2

Ninjin'yoeito is not administrated in patients with proximal hip fracture after surgery

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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 aged 65 years or older (when giving informed consent)
4) Patients who can take oral administrationof investigational drugs
5) Inpatients
6) Patients who are able to give written informed consent

Key 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

Target sample size

40

Name of lead principal investigator

1st name	Takuji
Middle name	MATSUMOTO
Last name	Matsumoto

Organization

Nokami Kosei General Hospital

Division name

Department of Orthopedic Surgery

Zip code

640-1141

Address

198, Shobata, Kinino-cho, Kaiso-gun, Wakayama

TEL

0734892178

Email

matsumoto_t@nokami-hospital.jp

Name of contact person

1st name	TAKUJI
Middle name	MATSUMOTO
Last name	MATSUMOTO

Organization

Nokami Kosei General Hospital

Division name

Department of Orthopedic Surgery

Zip code

640-1141

Address

198, Shobata, Kinino-cho, Kaiso-gun, Wakayama

TEL

0734892178

Homepage URL

Email

matsumoto_t@nokami-hospital.jp

Institute

Nokami Kosei General Hospital

Institute

Department

Personal name

Organization

Kracie

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Nokami Kosei General Hospital

Address

198, Shobata, Kinino-cho, Kaiso-gun, Wakayama

Tel

0734892178

Email

info@nokami-hospital.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

野上厚生総合病院（和歌山県）

Date of disclosure of the study information

2021

Year

05

Month

01

Day

URL releasing protocol

https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202202283782586022

Publication of results

Partially published

URL related to results and publications

https://jglobal.jst.go.jp/detail?JGLOBAL_ID=202202283782586022

Number of participants that the trial has enrolled

95

Results

ALB increased significantly in the NYT group at 2 and 4 weeks. CONUT scores improved significantly in the NYT group at 4 weeks after surgery. GNRI showed significant improvement throughout the postoperative period in the NYT group. MSR increased significantly in the NYT group at 2 weeks postoperatively and WLR decreased significantly less in the NYT group.

Results date posted

2023

Year

10

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2021

Year

10

Month

29

Day

Baseline Characteristics

Patients aged 65 years or older were diagnosed with HF(hip fracture) and underwent surgery at our hospital between April 2018 and March 2020.
There were no significant differences in age, gender, height, weight, %IBW, BMI, fracture type, MNA-SF, CONUT, and GNRI between the two groups of patients at admission. There were no significant differences in operative time, intraoperative blood loss, and length of hospital stay between the two groups. Antihistamines were taken in 1 patient with unexplained allergy and 1 patient with bronchial asthma. In the NYT group, steroids were taken by one patient with rheumatoid arthritis and one patient with nephrotic syndrome, and antihistamines were not taken by any patient, and there was no difference between the two groups (Fisher's direct probability, p = 0.805).

Participant flow

Patients: There were 120 patients with HF during the study period, with a mean age of 84.0 years, 23 males and 97 females. Of these, 110 patients consented to the study. There were 2 cases of refusal of medication and 3 cases of incomplete data, but no cases of worsening renal function, liver function, or allergic reactions. Eight cases of pneumonia and two cases of deep vein thrombosis/pulmonary embolism as perioperative complications were also excluded from the study. Excluding patients who met the exclusion criteria, there were 31 patients in the ginsen-yo-eito group (NYT group) and 64 patients in the control group (CT group) who were not treated with ginsen-yo-eito and were included in the analysis.

Adverse events

There were 2 cases of refusal of medication and 3 cases of incomplete data, but no cases of worsening renal function, worsening hepatic function, or allergic reactions. Eight cases of pneumonia and two cases of deep vein thrombosis/pulmonary embolism as perioperative complications were also excluded from the study.

Outcome measures

There were no significant differences in age, gender, height, weight, %IBW, BMI, fracture type, MNA-SF, CONUT, and GNRI between the two groups. There were no significant differences in operative time, intraoperative blood loss, and length of hospital stay between the two groups.
(1) Changes in nutritional indices
ALB increased significantly in the NYT group compared with the CT group at 2 and 4 weeks (1w; CT 2.6, NYT 2.8, p=0.13; 2w; CT 2.9, NYT 3.1, p<0.05; 4w; CT 3.0, NYT 3.3, p<0.05). CONUT values were significantly improved at 4 weeks in the NYT group compared with the CT group (4w; CT 4.7, NYT 3.3, p < 0.01). GNRI showed significant improvement throughout the postoperative period (1w; CT 73.8, NYT 80.0, p<0.05; 2w; CT 75.8, NYT 84.1, p<0.01; 4w; CT 78.3, NYT 87.9, p<0.01) (Figure 2d).
(2) Changes in dietary sufficiency and rate of weight loss
MSR increased in the NYT group compared with the CT group (1w; CT 77.2%, NYT 84.8%, p=0.06; 2w; CT 74.6%, NYT 85.8%, p<0.05; 4w; CT 76.8%, NYT 84.6%, p=0.08), and WLR decreased significantly in the NYT group compared with the CT group (1w WLR was significantly reduced in the NYT group compared with the CT group (1w; CT 2.2%, NYT-0.4%, p<0.05; 2w; CT 4.3%, NYT 0.04%, p<0.01; 4w; CT 4.75%, NYT-1.2%, p<0.01).
3) Evaluation of ADLs
FIM at 4 weeks postoperatively showed significant improvement in lower limb function in the NYT group (total items: CT 57.8, NYT 70.0, p=0.098; motor items: CT 38.9, NYT 47.2, p=0.11; lower limb function: CT 13.6, NYT 17.1 p<0.05; cognitive items: CT 18.9, NYT 22.8, p=0.05). Cognitive items: CT 18.9, NYT 22.8, p=0.098)

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2020

Year

07

Month

10

Day

Date of IRB

2020

Year

07

Month

10

Day

Anticipated trial start date

2021

Year

05

Month

01

Day

Last follow-up date

2021

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

04

Month

23

Day

Last modified on

2023

Year

10

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050269