UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050236 |
|---|---|
| Receipt number | R000057207 |
| Scientific Title | An Observational Study of Changes in Nutritional Status in Patients with Liver Cirrhosis after Treatment for Decreased Appetite with Rikkunshito |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2025/08/15 21:29:36 |
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Basic information
Public title
Does improvement of appetite with Rikkunshito improve the nutritional status of patients with liver cirrhosis?
Acronym
Rikkunshito study
Scientific Title
An Observational Study of Changes in Nutritional Status in Patients with Liver Cirrhosis after Treatment for Decreased Appetite with Rikkunshito
Scientific Title:Acronym
Observational study after treatment for decreased appetite
Region
| Japan |
Condition
Condition
Liver cirrhosis with decreased appetite
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the course of patients with cirrhosis after improvement of appetite.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum albumin level 12 weeks after the start of Rikkunshito treatment.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Liver cirrhosis patient with loss of appetite receiving treatment with Rikkunshito
Key exclusion criteria
1. Patients under 19 years old and over 80 years old
2. Patients with cancer
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 who have indicated their refusal to participate in the study
8. Patients with alcohol dependence
9. Dementia (PS2 or higher)
10. Patients with psychiatric disorders who are regularly attending or being hospitalized by a neuropsychiatrist and who are considered to have difficulty participating in the study
11. Other patients who are judged to be ineligible by the investigators and subinvestigators
12. Patients with other addictions
13. Patients with intellectual disability
14. Patients with cerebral organic mental disorder
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tatsuichi |
| Middle name | |
| Last name | An |
Organization
Bellland General Hospital
Division name
Department of Hepatology and 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
Department of Hepatology and 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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bellland General Hospital
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
| 2023 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://docs.google.com/document/d/13TgfllSR6hacvKSmy5Hysa77ZP7CnZXR/edit?usp=drive_link&ouid=111074
Publication of results
Partially published
Result
URL related to results and publications
https://docs.google.com/presentation/d/13GJ22fjtVBnSLJj-an6kntTYpUmV-8pe/edit?usp=drive_link&ouid=11
Number of participants that the trial has enrolled
10
Results
Primary endpoint: Change in serum albumin levels: The median value was 3.3 g/dl before rikkunshito administration, and after 3 months of administration, the mean value increased to 3.6 g/dl, demonstrating a statistically significant increase (P=0.011).
Results date posted
| 2025 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient background.
Three of the 10 cases dropped out, so only seven were analyzed.
Two cases had difficulty continuing to take Rikkunshito due to its unique taste.
One case discontinued treatment due to recurrence of hepatic encephalopathy.
Average age was 71 years old.
2 males, 5 females.
Child-Pugh score, which indicates liver reserve, was 6 in 1 case, 7 in 4 cases, 9 in 1 case, and 10 in 1 case, with 1 case each of Grade A and C, and 5 cases of Grade B.
No patients had sarcopenia.
No patients had HCC.
Appetite was assessed as 13 points using the SNAQ questionnaire, indicating a decrease in appetite, and this is considered to be in the group with anorexia.
AST (U/L) Average 32.0, standard deviation 5.10
ALT (U/L) Average 24.6, standard deviation 8.77
WBC (/microL) Average 4871, standard deviation 2422
Hb (g/dL) Average 11.3, standard deviation 2.13
PLT (10,000/microL) Average 11.3, standard deviation 7.00
Participant flow
Outpatients at Bellland General Hospital
Adverse events
Nothing
Outcome measures
2. Secondary Endpoints
2.1. Grip Strength
2.1.1. Right Hand
The median was 18.9 kg before rikkunshito administration and 20.2 kg after 3 months of administration, showing no statistically significant difference.
2.1.2. Left Hand
The median was 17.2 kg before rikkunshito administration and 16.5 kg after 3 months of administration, showing no statistically significant difference.
2.2. Skeletal Muscle Index
The median was 7.5 before rikkunshito administration and 7.3 after 3 months of administration, showing no statistically significant difference.
2.3. Body Weight
The median was 58 kg before rikkunshito administration and 59 kg after 3 months of administration, showing no statistically significant difference.
2.4. BMI
The median BMI was 23.6 before rikkunshito administration and 23.0 after 3 months of administration, showing no statistically significant difference.
2.5. HbA1c
The median HbA1c was 6.5% before rikkunshito administration and 6.3% after 3 months of administration, showing no statistically significant difference.
2.6. Child-Pugh Score
The median HbA1c was 7 before rikkunshito administration and 7 after 3 months of administration, showing no statistically significant difference.
2.7. MELD Score
The median HbA1c was 5 before rikkunshito administration and 6 after 3 months of administration, showing no statistically significant difference.
2.8. mALBI Score
The median HbA1c was -1.9 before rikkunshito administration and -2.2 after 3 months of administration, showing a statistically significant difference (P=0.004).
2.9. PT-INR
The median value was 1.03 before rikkunshito administration and 1.03 after 3 months of administration, showing no statistically significant difference.
2.10. Total Bilirubin
The median value was 1.8 mg/dL before rikkunshito administration and 1.6 mg/dL after 3 months of administration, showing no statistically significant difference.
2.11. Creatinine
The median value was 0.7 mg/dL before rikkunshito administration and 0.7 mg/dL after 3 months of administration, showing no statistically significant difference.
2.12. CLDQ Score
The median value was 5.4 before rikkunshito administration and 5.8 after 3 months of administration, showing a statistically significant difference (P=0.0156).
2.13 CLDQ Scores by Item
2.13.1. Abdominal symptoms
The median score was 5 before rikkunshito administration and 5.5 after 3 months of administration, showing no statistically significant difference.
2.13.2. Fatigue
The median score was 5 before rikkunshito administration and 5.2 after 3 months of administration, showing a statistically significant difference (P=0.031).
2.13.3. Systemic symptoms
The median score was 5.4 before rikkunshito administration and 6 after 3 months of administration, showing no statistically significant difference.
2.13.4. Activity/energy
The median score was 5 before rikkunshito administration and 5.8 after 3 months of administration, showing a statistically significant difference (P=0.0175).
2.13.5. Emotional health
The median score was 5.9 before rikkunshito administration and 6.2 after 3 months of administration, showing no statistically significant difference.
2.13.6. Worry
The median score was 5.2 before administration of Rikkunshito, and 6.2 after 3 months of administration, demonstrating a statistically significant difference (P=0.0156).
3. Safety Evaluation Items
No special notes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 08 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 15 | Day |
Other
Other related information
Single arm
Ovservation study
Pilot study
Management information
Registered date
| 2023 | Year | 02 | Month | 05 | 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=R000057207
