UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055024 |
|---|---|
| Receipt number | R000061163 |
| Scientific Title | Usefulness of Touki-Peonyaku-San in the treatment of fatigue in patients with chronic heart failure |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/01/19 11:39:04 |
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Basic information
Public title
An observational study to evaluate the efficacy and safety of Touki-Peonyaku-San for the treatment of fatigue in patients with chronic heart failure
Acronym
Usefulness of Touki-Peonyaku-San in the treatment of fatigue in heart failure
Scientific Title
Usefulness of Touki-Peonyaku-San in the treatment of fatigue in patients with chronic heart failure
Scientific Title:Acronym
Usefulness of Touki-Peonyaku-San in the treatment of fatigue in heart failure
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and efficacy of tokishakuyakusan for the treatment of fatigue in patients with heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
KCCQ-12subtitle(3); Comparison at the start of treatment, around 4 weeks after the start of treatment, and around 9 weeks after the start of treatment
Key secondary outcomes
KCCQ-12 summary score, KCCQ-12 domain scores(KCCQ12-PL, KCCQ12-SF, KCCQ12-QL, KCCQ12-SL),VAS(fatigue, sense of cold, diziness, palpitation, loss of appetite),labotratotry data(BNP, Cr, eGFR, Hb, Hct, Alb, Na, K, Cl), severeity of leg edema, cardio-thoracic ratio assessed by chest x-ray (CTR)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with chronic heart failure who have moderate or severe fatigue (as judged by the physician) and for whom TJ-23 is prescribed in the cardiology outpatient clinic
Key exclusion criteria
Patients less than 20 years of age, no more than moderate (as judged by the physician) fatigue at the start of TJ-23 will be excluded. Since this study will be conducted on an opt-out basis, patients will be excluded if they request to be excluded from the study
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Neiko |
| Middle name | |
| Last name | Ozasa |
Organization
Kyoto University Hospital
Division name
Kampo Medical Unit
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto City, Kyoto, JAPAN
TEL
0757514899
nei126@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Neiko |
| Middle name | |
| Last name | Ozasa |
Organization
Kyoto University Hospital
Division name
Kampo Medical Unit
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto City, Kyoto, JAPAN
TEL
0757514899
Homepage URL
nei126@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Institute of Biomedical Research and Innovation (NIBIO)
Institute
Department
Personal name
Neiko Ozasa
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Gradate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
0757534680
ethcom@kuhp.kyoto-u.ac.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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
A single-center, retrospective, observational study to evaluate the safety and efficacy of Touki-shakuyaku-san for the treatment of fatigue in patients with chronic heart failure
Management information
Registered date
| 2024 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061163
