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Exploratory study of hochuekkito for exercise capacity of patients with heart failure (HET Study)

Exploratory clinical study on efficacy and safety of hochuekkito for exercise capacity of patients with heart failure in home-based cardiac rehabilitation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031230348
Enrollment
30
Registered
2023-09-19
Start date
2023-12-21
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

Heart failure patients scheduled to undergo home-based cardiac rehabilitation heart failure

Interventions

hochuekkito administered three times daily (2.5 g each, 7.5 g / day)

Sponsors

Amiya Eisuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients performing home-based cardiac rehabilitation 2) Patients with stage C heart failure staging in ACCF/AHA guidelines 3) Patients who can walk independently 4) Patients aged 18 or older 5) Male or female 6) Patients who can take study drug orally 7) Patients who are able to provide written consent

Exclusion criteria

Exclusion criteria: 1) Patients with biventricular pacemaker placement or after implantation of a ventricular assist device 2) Patients with a history of heart transplantation 3) Patients at risk of severe arrhythmia, including ventricular tachycardia 4) Patients with serum potassium levels less than 3.0 mEq/L within 12 weeks before enrollment 5) Patients with severe liver or renal disorder 6) Patients with malignant tumors 7) Patients with mental illness who cannot respond to questionnaire surveys 8) Patients who have a history of allergies or side effects (such as pseudo aldosteronism) in kampo (herbal medicine) 9) Patients with a history of serious drug allergy such as anaphylactic shock or a history of serious side effects 10) Patients taking prohibited drugs or study drugs within 2 weeks before consent 11) Pregnant or potentially pregnant patients 12) Lactating patient 13) Patients with symptoms such as eczema and dermatitis 14) Other patients who are judged inappropriate for participation in this study by the investigator or co-investigator

Design outcomes

Primary

MeasureTime frame
Walk distance of six-minute walk test

Secondary

MeasureTime frame
1) Muscle strength (Grip strength) 2) Motivation (Apathy scale score) 3) Fatigue, Shortness of breath, Appetite (VAS) 4) QOL (EQ-5D-5L Japanese version) 5) Physical activity (Number of steps) 6) Nutrition (Body weight, Prealbumin) 7) Heart function (BNP)

Contacts

Public ContactEisuke Amiya

The University of Tokyo Hospital

amiyae-tky@umin.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026