The effect of Rikkunshito on The Nutritional Status in Patients With Chronic Heart Failure; A Prospective Randomized Controlled Trial (APPETIZE-HF trial)

未提供0 个研究点目标入组 80 人开始时间: 2023年6月23日最近更新: 2025年5月8日

试验速览

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•(1) Patients diagnosed with chronic heart failure:<1>Patients with a history of hospitalization for heart failure or <2>Patients with risk factors for heart failure, symptoms of heart failure such as shortness of breath, or abnormal ECG, and NT-proBNP>=125pg/ml or BNP>=35pg/ml which was measured at the timing within 3 months of informed consent, and some abnormal findings on echocardiography.
•(2) Patients with an appetite loss:CNAQ(Council on Nutrition appetite questionnaire)-J of 28 or less
•(3) Patients who are age 20 years and over on the day informed consent obtained and are adequate oral intake
•(4) Patients who can provide written consent

•(1) Patients using the implantable medical device
•(2) Patients with BMI > 23.5 kg/m2
•(3) Patients who have used Rikkunshito and/or other kampo medicines within 4 weeks before enrollment
•(4) Patients hospitalized for acute heart failure within 3 months before study consent
•(5) Patients scheduled for catheter intervention or ablation/cardiac surgery within the study period
•(6) Patients unable to stand (If patients can hold on, patients can register.)
•(7) Patients on dialysis
•(8) Patients with malignant disease with a prognosis considered to be within 6 months
•(9) Patients who received gastrectomy
•(10) Patients with a history of allergy to kampo medicines
•(11) Patients who are pregnant or potentially pregnant, patients breast-feeding, or patients aiming to become pregnant during the clinical trial
•(12) Patients who are ineligible in the opinion of the investigator

SMI

To evaluate the amount of change SMI by the BIA method using Seca mBCA 515 Medical Body Composition Analyzer.

发起方

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