Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease (NCT07174076) | Clinical Trial Compass
RecruitingPhase 4
Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease
China300 participantsStarted 2025-07-24
Plain-language summary
The goal of this clinical trial is to learn if cordyceps sinesis capsule (Bailiing Capsule) works to prevent the recurrence of microbiologically cured mycobacterium avium complex pulmonary disease in adults. The main questions it aims to answer are:
Does cordyceps sinesis capsule (Bailiing Capsule) prevents the recurrence of mycobacterium avium complex pulmonary disease in adults? Researchers will compare cordyceps sinesis capsule (Bailiing Capsule) to a placebo (a look-alike substance that contains no drug) to see if cordyceps sinesis capsule helps to prevent the recurrence of mycobacterium avium complex pulmonary disease.
Participants will:
Take cordyceps sinesis capsule (Bailiing Capsule) or a placebo (a look-alike substance that contains no drug) for 12 months, both are administered every day.
Visit the clinic once every 3 months for checkups and tests. Take online questionnaires every month.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients voluntarily participate in the study and sign the informed consent form.
✓. Age between 18 and 75 years, inclusive; gender unrestricted.
✓. Confirmed diagnosis of MAC (Mycobacterium avium complex) lung disease according to either the 2020 ATS/IDSA guidelines or the Chinese Guideline for Diagnosis and Treatment of Nontuberculous Mycobacterial Disease (2020 edition). Imaging findings at baseline must show a nodular bronchiectatic pattern prior to treatment initiation.
✓. Completed the recommended treatment regimen for nodular-bronchiectatic MAC lung disease (macrolide + ethambutol + rifampin, with minimum 12-month duration) per the above guidelines within 3 months prior to screening; Fully completed the anti-infective treatment phase of this study. Participants must achieve bacteriologic negativity (two consecutive negative sputum cultures with an interval ≥4 weeks) by the end of their treatment course.
✓. For non-surgically sterilized women of childbearing potential:
✓. Organ Function Requirements (Met Within 1 Week Prior to Enrollment):
. Any allergy to drugs included in the treatment regimen.
✕. Completed anti-MAC therapy for more than 3 months.
✕. Active respiratory tract infection.
✕. Presence of congenital/acquired immunodeficiency diseases, active pulmonary malignancies (primary or metastatic), or any malignant tumors requiring chemotherapy/radiotherapy during screening or the study period.
✕. Unstable concomitant systemic diseases (hypertensive crisis, unstable angina, congestive heart failure, myocardial infarction within the past 6 months, severe psychiatric disorders requiring medication, severe hepatic/renal dysfunction, neurodegenerative diseases such as Alzheimer's disease).