TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai University of Traditional Chinese Medicine

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

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

Treatment groups

352 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Shanghai University of Traditional Chinese Medicine

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Collaborator

Anhui Chest Hospital

Collaborator

Guangzhou Chest Hospital.

Collaborator

Jiangxi Chest Hospital

Collaborator

Beijing Chest Hospital

Collaborator

China-Japan Friendship Hospital

Collaborator

Huashan Hospital

Collaborator