Mycobacterium Avium Complex Pulmonary DiseasePhase 4NCT07174076
Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease
A Phase 4 study testing cordyceps sinesis capsule in people with Mycobacterium Avium Complex Pulmonary Disease, run by Bin Cao at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mycobacterium Avium Complex Pulmonary Disease
- What is being tested?
- cordyceps sinesis capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 6 sitesChina
- Study dates
- 24 Jul 2025to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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):
- 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.
Who cannot join
- 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.
- History of solid organ transplantation.
- Currently undergoing dialysis.
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- Radiographic pneumonia requiring steroid/immunoglobulin pulse therapy, clinically evident active interstitial lung disease, uncontrolled massive pleural effusion/pericardial effusion.
- 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).
- Poor gastrointestinal function or malabsorption syndrome.
- Receipt of other investigational drugs (excluding participation of 2025-KY-004-1) within 4 weeks prior to the first administration of study drug.
- Participation in another interventional clinical trial simultaneously, except for observational/non-interventional trials or follow-up periods of interventional trials.
- Any physical examination findings or clinical laboratory results that the investigator believes may interfere with study outcomes or pose increased risks of complications for the patient's management.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
- Not yet recruiting
Guangzhou Chest Hospital
Guangzhou, Guangdong
- Recruiting
Anhui Chest Hospital
Hefei, Anhui
- Recruiting
Jiangxi Chest Hospital
Nanchang, Jiangxi
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
About this study
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.
Read more
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.
- Being tested
- cordyceps sinesis capsule, cordyceps sinesis capsule placebo
- Keywords
- mycobacerium avium complex, recurrence, cordyceps sinesis
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cordyceps sinesis capsuleDrug
cordyceps sinesis capsule 4 capsules tid po for 12 months
cordyceps sinesis capsule placeboDrug
cordyceps sinesis capsule placebo 4 capsules tid po for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Cordyceps sinesis | Experimental | cordyceps sinesis capsule 4# tid for 12 months Receives: Drug: cordyceps sinesis capsule |
| Placebo | Placebo comparator | placebo 4# tid for 12 months Receives: Drug: cordyceps sinesis capsule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial recurrence of MAC-PD
Measured: from enrollment to the end of month 12
Secondary outcomes (1)
occurrence of respiratory infection
Measured: from enrollment to the end of month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start24 Jul 2025
- Primary completion24 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Avium Complex Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Cao
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Jiangxi Chest Hospital, Guangzhou Chest Hospital., Anhui Chest Hospital, Beijing Chest Hospital, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., Weifang Second People's Hospital, China, Changsha Central Hospital, Shandong Public Health Clinical Center
- Responsible party
- Sponsor-investigator, Bin Cao, Capital Medical University
- Investigators
- Xiaojing Cui, M.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174076
- Sponsor's protocol ID
- 2025-KY-004-1
- Status last verified
- Nov 2026
- First submitted
- 22 Jul 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07174076
- Acronym / sponsor ID
- 2025-KY-004-1
- Keywords
- mycobacerium avium complex, recurrence, cordyceps sinesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bin CaoUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Jiangxi Chest Hospital, Guangzhou Chest Hospital., Anhui Chest Hospital, Beijing Chest Hospital, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., Weifang Second People's Hospital, China, Changsha Central Hospital, Shandong Public Health Clinical Center
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 24 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cordyceps sinesis | Experimental | Drug: cordyceps sinesis capsulecordyceps sinesis capsule 4# tid for 12 months |
| Placebo | Placebo comparator | Drug: cordyceps sinesis capsule placeboplacebo 4# tid for 12 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (12 listed)
- 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.
- History of solid organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cordyceps sinesis capsulecordyceps sinesis capsule 4 capsules tid po for 12 months | Drug | Cordyceps sinesis |
| cordyceps sinesis capsule placebocordyceps sinesis capsule placebo 4 capsules tid po for 12 months | Drug | Placebo |
Primary outcome
bacterial recurrence of MAC-PD
Time frame: from enrollment to the end of month 12
1 secondary outcome
occurrence of respiratory infection
Time frame: from enrollment to the end of month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaojing Cui, M.D. principal investigator
China-Japan Friendship Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cordyceps sinesis capsule in people with Mycobacterium Avium Complex Pulmonary Disease, run by Bin Cao at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siwei Gu, M.D. (+86 010 84205566, orbitline2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial recurrence of MAC-PD (time frame: from enrollment to the end of month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.