Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
| Shanghai Pulmonary Hospital, Shanghai, China | OTHER |
| Jiangxi Chest Hospital | UNKNOWN |
| Guangzhou Chest Hospital. |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cordyceps sinesis | Experimental | cordyceps sinesis capsule 4# tid for 12 months |
|
| Placebo | Placebo Comparator | placebo 4# tid for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cordyceps sinesis capsule | Drug | cordyceps sinesis capsule 4 capsules tid po for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| bacterial recurrence of MAC-PD | from enrollment to the end of month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of respiratory infection | from enrollment to the end of month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events and laboratory findings | from enrollment to the end of month 12 | |
| recurrent MAC strain subtype | from enrollment to the end of month 12 |
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:
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.
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 <2× ULN or creatinine clearance ≥60 mL/min; viii. Blood urea nitrogen (BUN) ≤200 mg/L; ix. Urine protein <++ on dipstick; if trace (+), 24-hour urine protein must be <500 mg; x. Fasting glucose within normal range **or** controlled stable glycemic levels in diabetic patients; xi. Cardiac function: No myocardial infarction in the past 6 months, no unstable angina, no severe arrhythmias, and New York Heart Association (NYHA) functional class ≤II.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siwei Gu, M.D. | Contact | +86 010 84205566 | orbitline2@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojing Cui, M.D. | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Chest Hospital | Recruiting | Hefei | Anhui | China | ||
| Beijing Chest Hospital, Capital Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| OTHER |
| Anhui Chest Hospital | OTHER |
| Beijing Chest Hospital | OTHER |
| Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
| cordyceps sinesis capsule placebo | Drug | cordyceps sinesis capsule placebo 4 capsules tid po for 12 months |
|
| Not yet recruiting |
| Beijing |
| Beijing Municipality |
| China |
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | China |
| Guangzhou Chest Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
| Jiangxi Chest Hospital | Recruiting | Nanchang | Jiangxi | China |
| Shanghai Pulmonary Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |