TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease (NCT07295938) | Clinical Trial Compass
RecruitingPhase 2
TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease
China352 participantsStarted 2025-09-08
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 radiothera…
What they're measuring
1
Clinical cure rate
Timeframe: At the end of 52 weeks of treatment
2
Relapse or reinfection rates
Timeframe: At the end of 52 weeks of treatment
Trial details
NCT IDNCT07295938
SponsorShanghai University of Traditional Chinese Medicine