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Recruiting Phase 4 NCT07174076

Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease

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Trial Parameters

Condition Mycobacterium Avium Complex Pulmonary Disease
Sponsor Bin Cao
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-07-24
Completion 2028-07-24
Interventions
cordyceps sinesis capsulecordyceps sinesis capsule placebo

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Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Patients voluntarily participate in the study and sign the informed consent form. 2. Age between 18 and 75 years, inclusive; gender unrestricted. 3. 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. 4. 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. 5. For non-surgically sterilized women of childbearin

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