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Clinical Trials in China / NCT07295938
Recruiting Phase 2

TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease

NCT07295938 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (8)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT07295938 on ClinicalTrials.gov ↗ ← All trials in China