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TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease

RecruitingPhase 2Ages 18 Years - 75 YearsAllShanghai University of Traditional Chinese Medici…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Chinese herbs-I
  • Chinese herbs-I placebo
  • Chinese herbs-II
  • Chinese herbs-II placebo
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Where

8 sites
Beijing Chest Hospital Affiliated to Capital Medical University
Beijing, China
China-Japan Friendship Hospital
Beijing, China
Guangzhou Municipal Hospital of Chest Medicine
Guangdong, China
Anhui Provincial Chest Hospital
Hefei, China
Jiangxi Chest Hospital
Nanchang, China
Fudan University Affiliated Huashan Hospital
Shanghai, China
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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