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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000031859 |
Receipt No. | R000036383 |
Scientific Title | Multicenter study of Kampo treatment for frailty in aged patients |
Date of disclosure of the study information | 2018/03/23 |
Last modified on | 2018/10/09 |
Basic information | ||
Public title | Multicenter study of Kampo treatment for frailty in aged patients | |
Acronym | Multicenter study of Kampo treatment for frailty in aged patients | |
Scientific Title | Multicenter study of Kampo treatment for frailty in aged patients | |
Scientific Title:Acronym | Multicenter study of Kampo treatment for frailty in aged patients | |
Region |
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Condition | ||||
Condition | Frailty | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to evaluate the efficacy of Ninjinyoeito, Kampo formulas, for frailty in aged patients on physical activity using activity meter, blood sample and psychological examination. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Number of steps and physical activity |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | 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 |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Patients who meet a criterion for frailty
2)ambulatory patients |
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Key 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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kagoshima University Graduate School of Medical and Dental Sciences | ||||||
Division name | Department of Psychosomatic Internal Medicine | ||||||
Zip code | |||||||
Address | 8-35-1 Sakuragaoka, Kagoshima City, Kagoshima, Japan | ||||||
TEL | 099-275-5751 | ||||||
inui@m.kufm.kagoshima-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kagoshima University Graduate School of Medical and Dental Sciences | ||||||
Division name | Department of Psychosomatic Internal Medicine | ||||||
Zip code | |||||||
Address | 8-35-1 Sakuragaoka, Kagoshima City, Kagoshima, Japan | ||||||
TEL | 099-275-5751 | ||||||
Homepage URL | |||||||
amitani@m3.kufm.kagoshima-u.ac.jp |
Sponsor | |
Institute | Kagoshima University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Kracie Pharmaceutical,Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036383 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |