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Recruiting NCT07174076

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

Conditions: Mycobacterium Avium Complex Pulmonary Disease

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 300
Sponsor: Bin Cao

Location: Anhui Chest Hospital Hefei Anhui

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 childbearing potential: Must use a medically approved contraceptive method (e.g., intrauterine device, hormonal contraceptives, or condoms) during the study period and for 3 months post-last treatment dose. A negative serum/urine pregnancy test must be confirmed within 72 hours prior to enrollment. Must not be lactating at screening. For male participants with partners of childbearing potential: Must use effective contraception during the study and for 3 months post-last treatment dose. 6. Organ Function Requirements (Met Within 1 Week Prior to Enrollment): i. Hemoglobin ≥60 g/L; ii. Neutrophil count ≥0.5 × 10⁹/L; iii. Platelet count ≥60 × 10⁹/L; iv. Serum total bilirubin ≤3× upper limit of normal (ULN); v. Aspartate aminotransferase (AST) ≤3× ULN; vi. Alanine aminotransferase (ALT) ≤3× ULN; vii. Serum creatinine \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07174076). StuddyBuddy aggregates publicly available trial information.