Actively Recruiting
TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease
Led by Shanghai University of Traditional Chinese Medicine · Updated on 2025-12-22
352
Participants Needed
8
Research Sites
164 weeks
Total Duration
On this page
Sponsors
S
Shanghai University of Traditional Chinese Medicine
Lead Sponsor
S
Shanghai Pulmonary Hospital, Shanghai, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Mycobacterium abscessus pulmonary disease
- Completed the initial treatment phase as recommended by guidelines
- Provided written informed consent
- One week prior to enrollment, organ function meets all of the following: hemoglobin 60g/L; neutrophil count 50.5�D710^9/L; platelet count 60�D710^9/L; serum total bilirubin 643 times the upper limit of normal; aspartate aminotransferase 643 times the upper limit of normal; alanine aminotransferase 643 times the upper limit of normal; creatinine below 2 times the upper limit of normal or creatinine clearance 60mL/min; urea nitrogen 60200mg/L; urinary protein less than ++, with 500mg total protein in 24-hour urine if protein is present; blood glucose within normal range or stable blood glucose control if diabetic; no recent myocardial infarction within 6 months; no unstable angina; no severe arrhythmia
You will not qualify if you...
- Allergy to the investigational medication
- Infection with two or more non-tuberculous mycobacteria or active pulmonary tuberculosis
- Prior history of pulmonary parenchymal organ transplantation
- Severe conditions including congenital or acquired immunodeficiency, active malignant tumors requiring treatment
- Undergoing dialysis
- Radiation pneumonitis needing corticosteroid or immunoglobulin pulse therapy, active interstitial lung disease, uncontrolled massive pleural or pericardial effusion
- Unstable systemic comorbidities such as hypertensive crisis, unstable angina, recent myocardial infarction, severe psychiatric disorders requiring medication, severe liver or kidney dysfunction, Alzheimer’s disease
- Intestinal dysfunction or malabsorption syndrome
- Pregnant or breastfeeding women
- Use of other investigational drugs within 4 weeks before starting study treatment
- Concurrent enrollment in other clinical trials except observational or follow-up visits
- Physical exams or clinical tests judged by investigators to interfere with results or increase treatment risks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Beijing Chest Hospital Affiliated to Capital Medical University
Beijing, China
Not Yet Recruiting
2
China-Japan Friendship Hospital
Beijing, China
Not Yet Recruiting
3
Guangzhou Municipal Hospital of Chest Medicine
Guangdong, China
Actively Recruiting
4
Anhui Provincial Chest Hospital
Hefei, China
Actively Recruiting
5
Jiangxi Chest Hospital
Nanchang, China
Not Yet Recruiting
6
Fudan University Affiliated Huashan Hospital
Shanghai, China
Not Yet Recruiting
7
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, China
Actively Recruiting
8
Shanghai Pulmonary Hospital
Shanghai, China
Actively Recruiting
Research Team
S
Shaoyan Zhang
CONTACT
Z
Zhenhui Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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