An observational study to evaluate the efficacy and safety of Touki-Peonyaku-San for the treatment of fatigue in patients with chronic heart failure

Usefulness of Touki-Peonyaku-San in the treatment of fatigue in patients with chronic heart failure - Usefulness of Touki-Peonyaku-San in the treatment of fatigue in heart failure

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055024

Enrollment

Registered

2024-08-01

Start date

2024-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic heart failure

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactNeiko Ozasa

Kyoto University Hospital Kampo Medical Unit

nei126@kuhp.kyoto-u.ac.jp0757514899

Outcome results