臨床研究等提出・公開システム

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)

Ninjinyoeito for nontuberculous mycobacterial pulmonary disease with weight loss and anorexia (NYT for NTM-PD)

Morimoto Kozo

Fukujuji Hospital, Japan Anti-Tuberculosis Association

3-1-24 Matsuyama, Kiyose, Tokyo

morimotok@fukujuji.org

Ito Masashi

Fukujuji Hospital, Japan Anti-Tuberculosis Association

3-1-24 Matsuyama, Kiyose, Tokyo

+81-42-491-4111

itom@fukujuji.org

Recruiting

Jan. 18, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

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

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

Both

nontuberculous mycobacterial pulmonary disease

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. The dose of Ninjinyoeito may be reduced to 2/3 (5.0 g/day, twice a day) depending on the patient's age and symptoms.
arm B: Follow-up for 24 weeks. If there is existing conventional treatment, it will be continued.

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

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

+81-25-368-9343

Dec. 19, 2022

No

none