UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053809 |
|---|---|
| Receipt number | R000061416 |
| Scientific Title | Analysis of the Effect of Stress-Free Therapy on Liver Function Test Values |
| Date of disclosure of the study information | 2024/03/08 |
| Last modified on | 2024/03/10 12:08:05 |
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Basic information
Public title
Analysis of the Effect of Stress-Free Therapy on Liver Function Test Values - A Retrospective Observational Study
Acronym
Analysis of the Effect of Stress-Free Therapy on Liver Function Test Values
Scientific Title
Analysis of the Effect of Stress-Free Therapy on Liver Function Test Values
Scientific Title:Acronym
Analysis of the Effect of Stress-Free Therapy on Liver Function Test Values
Region
| Japan |
Condition
Condition
Subjects who received treatment with stress-free therapy
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that liver function test values would improve more after stress-free therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine changes in blood AST, ALT, and GGT levels before and after stress-free therapy, and to determine the relationship between stress-free therapy and liver function tests.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women who are at least 18 years of age at the time of the stress-free therapy
Key exclusion criteria
(i) Patients with mental illness, alcoholism, drug addiction, or narcotic addiction that would affect compliance with the research protocol
(ii) Subjects who have requested to refuse the research
(iii) Patients whom the principal investigator or subinvestigator determines are not suitable for the research.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International university of health and welfare Narita hospital
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476355600
takaomi0027@gmail.com
Public contact
Name of contact person
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International university health and welfare Narita hospital
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476355600
Homepage URL
takaomi0027@gmail.com
Sponsor or person
Institute
International university of health and welfare Narita 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
International university health and welfare Narita hospital
Address
852, Hatakeda, Narita, Chiba
Tel
0476355600
takaomi0027@gmail.com
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 | 03 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061416
