Actively Recruiting
Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease
Led by Bin Cao · Updated on 2025-09-15
300
Participants Needed
6
Research Sites
179 weeks
Total Duration
On this page
Sponsors
B
Bin Cao
Lead Sponsor
C
China-Japan Friendship Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 lung disease according to 2020 ATS/IDSA or Chinese guidelines with nodular bronchiectatic pattern before treatment.
- Completed recommended treatment for nodular-bronchiectatic MAC lung disease (macrolide + ethambutol + rifampin) for at least 12 months within 3 months prior to screening.
- Achieved bacteriologic negativity with two consecutive negative sputum cultures at least 4 weeks apart by treatment end.
- Women of childbearing potential must use approved contraception during the study and for 3 months after; negative pregnancy test within 72 hours prior to enrollment; must not be lactating.
- Male participants with partners of childbearing potential must use effective contraception during the study and for 3 months after.
- Organ function requirements met within 1 week prior to enrollment, including specific blood counts, liver and kidney function tests, cardiac function, and controlled glucose levels.
You will not qualify if you...
- Allergy to drugs included in the treatment regimen.
- Completed anti-MAC therapy more than 3 months ago.
- Active respiratory tract infection.
- Presence of immunodeficiency diseases, active pulmonary malignancies, or other cancers requiring chemotherapy/radiotherapy during screening or study.
- History of solid organ transplantation.
- Currently undergoing dialysis.
- Radiographic pneumonia requiring steroid/immunoglobulin therapy, active interstitial lung disease, or uncontrolled massive pleural/pericardial effusion.
- Unstable systemic diseases such as hypertensive crisis, unstable angina, recent myocardial infarction, severe psychiatric disorders, severe hepatic/renal dysfunction, or neurodegenerative diseases.
- Poor gastrointestinal function or malabsorption syndrome.
- Use of other investigational drugs within 4 weeks before first study drug dose (excluding certain exceptions).
- Participation in another interventional clinical trial simultaneously, except observational or follow-up trials.
- Any clinical findings or lab results that may interfere with study outcomes or increase risk as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Anhui Chest Hospital
Hefei, Anhui, China
Actively Recruiting
2
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
Guangzhou Chest Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
5
Jiangxi Chest Hospital
Nanchang, Jiangxi, China
Actively Recruiting
6
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
Research Team
S
Siwei Gu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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