Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
JPRN |
Last refreshed on:
|
17 October 2023 |
Main ID: |
JPRN-UMIN000031859 |
Date of registration:
|
23/03/2018 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Multicenter study of Kampo treatment for frailty in aged patients
|
Scientific title:
|
Multicenter study of Kampo treatment for frailty in aged patients - Multicenter study of Kampo treatment for frailty in aged patients |
Date of first enrolment:
|
2017/03/14 |
Target sample size:
|
60 |
Recruitment status: |
Recruiting |
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036383 |
Study type:
|
Interventional |
Study design:
|
Single arm Non-randomized
|
Phase:
|
Not selected
|
|
Countries of recruitment
|
Japan
| | | | | | | |
Contacts
|
Name:
|
Haruka Amitani |
Address:
|
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima, Japan
Japan |
Telephone:
|
099-275-5751 |
Email:
|
amitani@m3.kufm.kagoshima-u.ac.jp |
Affiliation:
|
Kagoshima University Graduate School of Medical and Dental Sciences Department of Psychosomatic Internal Medicine |
|
Name:
|
Akio Inui |
Address:
|
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima, Japan
Japan |
Telephone:
|
099-275-5751 |
Email:
|
inui@m.kufm.kagoshima-u.ac.jp |
Affiliation:
|
Kagoshima University Graduate School of Medical and Dental Sciences Department of Psychosomatic Internal Medicine |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: 1)Patients who have taken crude drug product within 2 weeks before enrollment 2)Patients suspected of having dementia (MMSE score 23 or below) 3)Patients with a history of Parkinson disease or stroke 4)Patients with serious complications (e.g., hepatic or cardiac diseases) 5)Other patients who are assessed to be inappropriate for study participation by the investigator, or other relevant persons
Age minimum:
65years-old
Age maximum:
90years-old
Gender:
Male and Female
|
Health Condition(s) or Problem(s) studied
|
Frailty
|
Intervention(s)
|
Ninjinyoeito Administered orally at a dose of 7.5 g/day in two or three divided doses before or between meals. Adjust the dose as needed according to the age, body weight and symptoms of patients. Treatment duration: 3 or 6 months
|
Primary Outcome(s)
|
Number of steps and physical activity
|
Source(s) of Monetary Support
|
Kracie Pharmaceutical,Ltd.
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|