nontuberculous mycobacterial pulmonary disease
Conditions
Interventions
Patients are randomly assigned to the following two groups.
arm A: Kracie Ninjinyoeito extract fine granules 2.5 g three times a day for 24 weeks. If there is existing treatment, it will be continued.
Sponsors
Morimoto Kozo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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 2) Patients with SNAQ score of 14 or less or who are judged by the principal investigator (subinvestigator) to have insufficient food intake 3) Patients with BMI<20 and more than 2% weight loss within 24 months 4) Patients who have given their written consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) Patients with other respiratory diseases with unstable symptoms (chronic obstructive pulmonary disease, asthma, etc.) 2) Patients with confirmed or suspected active malignancy 3) Patients with diabetes mellitus 4) Patients with a history of gastrectomy 5) Patients with unstable gastrointestinal disease 6) Patients with serious hepatic dysfunction (AST or ALT level of at least 3 times the institutional reference value within 3 months of obtaining consent) 7) 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) 8) Patients with a history of hypersensitivity to any component of the study drug 9) Patients with a history of taking Kampo medicines 2 weeks before the date of main registration 10) Patients who are taking oral or injection steroids 11) Patients who are pregnant or may become pregnant during the study period or who are breast-feeding 12) Patients who are participating in other clinical trials or have completed their participation within 1 month 13) Patients who are deemed ineligible by the investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight before and after treatment (baseline to 24 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount and percent change before and after treatment (from baseline to 12 and 24 weeks) in the following items 1) Body weight 2) BMI 3) SNAQ 4) SF-36 5) CAT 6) mMRC 7) Muscle mass (lean body mass) 8) Fat mass 9) Blood biochemical tests: active ghrelin, inactive gherelin, adiponectin, leptin, TNF-a, IL-6, albumin, prealbumin | — |
Contacts
Public ContactMasashi Ito
Fukujuji Hospital, Japan Anti-Tuberculosis Association
Outcome results
None listed