TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease
A Study to Assess the Traditional Chinese Medicine as Adjunctive Therapy to Improve Cure Rates During the Continuation Phase in Mycobacterium Abscessus Pulmonary Disease
Shanghai University of Traditional Chinese Medicine
352 participants
Sep 8, 2025
INTERVENTIONAL
Conditions
Summary
Chinese herbs can facilitate sputum culture conversion, promote lesion absorption, and enhance clinical symptoms and quality of life for patients with Mycobacterium abscessus pulmonary disease (MAB-PD). The investigators aimed to evaluate the efficacy of Chinese herbs as adjunct therapy to improve cure rates or reduce recurrence rates during the continuation phase of MAB-PD treatment.
Eligibility
Inclusion Criteria4
- Patient diagnosed with Mycobacterium abscessus pulmonary disease;
- Patients have completed the initial phase of treatment as recommended by the guidelines;
- Patients who have given written informed consent
- One week prior to enrollment, organ function levels must meet the following criteria: a. Hemoglobin ≥60g/L; b. Neutrophil count ≥0.5×10\^9/L; c. Platelet count ≥60×10\^9/L; d. Serum total bilirubin ≤3 times the upper limit of normal; e. Aspartate aminotransferase ≤3 times the upper limit of normal; f. Alanine aminotransferase ≤3 times the upper limit of normal; g. Creatinine level below 2 times the upper limit of normal or creatinine clearance ≥60mL/min; h. Urea nitrogen ≤200mg/L; i. Urinary protein <++, with ≥500mg total protein in 24-hour urine if protein is present; j. Blood glucose: within normal range and/or stable blood glucose control in diabetic patients; k. Cardiac function: no history of myocardial infarction within 6 months; no unstable angina; no severe arrhythmia.
Exclusion Criteria12
- Patients with a drug allergy to the investigational medication;
- Patients infected with two or more non-tuberculous mycobacteria, or those with active pulmonary tuberculosis;
- Patients with a prior history of pulmonary parenchymal organ transplantation;
- Patients with severe conditions such as congenital or acquired immunodeficiency disorders, active malignant tumors (primary or metastatic), or any malignancies requiring chemotherapy or radiotherapy during screening or study;
- Patients undergoing dialysis;
- Patients with radiation pneumonitis requiring corticosteroid or immunoglobulin pulse therapy, or clinically proven active interstitial lung disease, uncontrolled massive pleural effusion, or pericardial effusion;
- Unstable systemic comorbidities (hypertensive crisis, unstable angina, congestive heart failure, myocardial infarction within the past 6 months, severe psychiatric disorders requiring medication, severe hepatic or renal dysfunction, neuropsychiatric conditions such as Alzheimer's disease);
- Patients with intestinal dysfunction or malabsorption syndrome;
- Pregnant or breastfeeding women;
- Patients receiving other investigational drugs within 4 weeks prior to first exposure to the study drug;
- Concurrent enrollment in another clinical trial, except for observational (non-interventional) studies or follow-up visits in interventional trials;
- Physical examinations or clinical tests that the investigator deems potentially interfering with results or increasing treatment-related complications.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
This is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease for a long time
Chinese herbs-I placebo
This is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease during the continuation phase for a long time
Chinese herbs-II placebo
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07295938