An open-label, randomized, controlled study of Ninjinyoeito for nontuberculous mycobacterial pulmonary disease with weight loss and anorexia (NYT for NTM-PD with weight loss and anorexia)

未提供0 个研究点目标入组 50 人开始时间: 2023年8月30日最近更新: 2024年8月21日

试验速览

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•Patients aged 18 years and over who meet the diagnostic criteria for NTM pulmonary disease of the Japanese Society for Tuberculosis and Japanese Respiratory Society
•Patients with SNAQ score of 14 or less or who are judged by the principal investigator (subinvestigator) to have insufficient food intake
•Patients with BMI<20 and more than 2% weight loss within 24 months
•Patients who have given their written consent to participate in this study

•Patients with other respiratory diseases with unstable symptoms (chronic obstructive pulmonary disease, asthma, etc.)
•Patients with confirmed or suspected active malignancy
•Patients with diabetes mellitus
•Patients with a history of gastrectomy
•Patients with unstable gastrointestinal disease
•Patients with serious hepatic dysfunction (AST or ALT level of at least 3 times the institutional reference value within 3 months of obtaining consent)
•Patients receiving continuous drug treatment for NTM pulmonary disease within 6 months(Discontinuation of amikacin injection or amikacin liposome inhalation suspension is not considered as a change in treatment)
•Patients with a history of hypersensitivity to any component of the study drug
•Patients with a history of taking Kampo medicines 2 weeks before the date of main registration
•Patients who are taking oral or injection steroids
•Patients who are pregnant or may become pregnant during the study period or who are breast-feeding
•Patients who are participating in other clinical trials or have completed their participation within 1 month
•Patients who are deemed ineligible by the investigator's judgment

Change in body weight before and after treatment (baseline to 24 weeks)

Body weight(baseline to 12 and 24 weeks)
BMI(baseline to 12 and 24 weeks)
SNAQ(baseline to 12 and 24 weeks)
SF-36(baseline to 12 and 24 weeks)
CAT(baseline to 12 and 24 weeks)
mMRC(baseline to 12 and 24 weeks)
Muscle mass (lean body mass)(baseline to 12 and 24 weeks)
Fat mass(baseline to 12 and 24 weeks)
Blood biochemical tests: active ghrelin, inactive gherelin, adiponectin, leptin, TNF-a, IL-6, albumin, prealbumin(baseline to 12 and 24 weeks)

发起方

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