Shanghai University of Traditional Chinese Medicine
Phase
Phase 2
Started
2025-09-08
Last updated
2025-12-22
Condition(s) studied
Mycobacterium Abscessus Pulmonary Disease
Investigational drug(s) / intervention(s)
Chinese herbs-IChinese herbs-I placeboChinese herbs-IIChinese herbs-II placebo
Chinese herbs-I: 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: Chinese herbs-I placebo
Chinese herbs-II: 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: Chinese herbs-II placebo
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
Clinical cure rate — At the end of 52 weeks of treatment Measured the change from the Baseline to the end of treatment. The sputum MAB culture was negative on three consecutive occasions, with at least a one-month interval between each, and there were no subsequent positive results.
Relapse or reinfection rates — At the end of 52 weeks of treatment Bacterial relapse is defined as the occurrence of at least two cultures and/or molecular biology tests identifying the same pathogenic M. abscessus strain as the initial infection after completing anti-M. abscessus treatment. When necessary, genotyping techniques may be employed to differentiate between relapse and reinfection. Reinfection refers to the emergence of different pathogenic strains or species in at least two positive cultures following the initiation of treatment.
Trial sites (8)
Facility
City
Region
Status
Beijing Chest Hospital Affiliated to Capital Medical University
Beijing
China
Not Yet Recruiting
China-Japan Friendship Hospital
Beijing
China
Not Yet Recruiting
Guangzhou Municipal Hospital of Chest Medicine
Guangdong
China
Recruiting
Anhui Provincial Chest Hospital
Hefei
China
Recruiting
Jiangxi Chest Hospital
Nanchang
China
Not Yet Recruiting
Fudan University Affiliated Huashan Hospital
Shanghai
China
Not Yet Recruiting
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai
China
Recruiting
Shanghai Pulmonary Hospital
Shanghai
China
Recruiting
More Shanghai University of Traditional Chinese Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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