UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056358 |
|---|---|
| Receipt number | R000064389 |
| Scientific Title | The effect of Ninjinyoeito on patients with chronic liver disease complicated by sarcopenia:A single-center prospective pilot study |
| Date of disclosure of the study information | 2024/12/04 |
| Last modified on | 2025/08/15 21:31:59 |
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Basic information
Public title
The effect of Ninjinyoeito on patients with chronic liver disease complicated by sarcopenia:A single-center prospective pilot study
Acronym
The effect of Ninjinyoeito on patients with chronic liver disease complicated by sarcopenia:A single-center prospective pilot study
Scientific Title
The effect of Ninjinyoeito on patients with chronic liver disease complicated by sarcopenia:A single-center prospective pilot study
Scientific Title:Acronym
The effect of Ninjinyoeito on patients with chronic liver disease complicated by sarcopenia:A single-center prospective pilot study
Region
| Japan |
Condition
Condition
Patients with chronic liver disease complicated with sarcopenia requiring treatment with ginsen-yo-eito due to post-illness loss of strength, fatigue, anorexia, sweating, cold hands and feet, and anemia
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the usefulness and safety of ginsen-yo-eito for patients with chronic liver disease complicated by sarcopenia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All scores on the Chronic Liver Disease Questionnaire
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
| Medicine |
Interventions/Control_1
For 6 months, Kracie Ninjin Yoeito is orally administered daily before or between meals in 2 divided doses of 7.5 g per day.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with at least one symptom of post-illness loss of strength, fatigue, anorexia, sweating, cold hands and feet, or anemia who receive treatment with Ninjin Yoeito
2. Patients who meet the criteria for sarcopenia proposed by the Japan Society of Hepatology (2nd edition)
3. Patients between 20 and 80 years of age, any gender
4. Patients who understand the contents of the consent document and are able to sign the consent form freely and voluntarily
Key exclusion criteria
1. Patients under 19 years old and over 80 years old
2. cancer-bearing patient
3. Pregnant and lactating patients
4. Patients with poorly controlled ascites
5. Patients with poorly controlled hepatic encephalopathy
6. Patients with severely impaired renal function (eGFR<30 ml/min/1.73m2)
7. Patients with confirmed refusal to participate
8. Patients showing signs of alcohol dependence
9. Dementia (PS2 or higher)
10. Patients with psychosis who are regularly attending or hospitalized in a neuropsychiatric department and who are considered to be difficult to participate in the study
11. Other patients deemed ineligible by the investigators and subinvestigators
12. Patients with other addictions
13. Patients with intellectual disabilities
14. Patients with cerebral organic mental disorders
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tatsuichi |
| Middle name | |
| Last name | An |
Organization
Bellland General Hospital
Division name
gastroenterology
Zip code
599-8247
Address
500-3 Higashiyama, Naka-ku, Sakai City, Osaka, Japan
TEL
072-234-2001
t_an@seichokai.or.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Aihara |
Organization
Bellland General Hospital
Division name
gastroenterology
Zip code
599-8247
Address
500-3 Higashiyama, Naka-ku, Sakai City, Osaka, Japan
TEL
072-234-2001
Homepage URL
y_aihara@seichokai.or.jp
Sponsor or person
Institute
Bellland General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bellland General Hospital Clinical Research Review Committee
Address
500-3 Higashiyama, Naka-ku, Sakai City, Osaka, Japan
Tel
072-234-2001
irb@bh.seichokai.or.jp
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
| 2024 | Year | 12 | Month | 04 | Day |
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
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064389
