Mycobacterium Abscessus Pulmonary DiseasePhase 2NCT07295938
TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease
A Phase 2 study testing Chinese herbs-I and Chinese herbs-II in people with Mycobacterium Abscessus Pulmonary Disease, run by Shanghai University of Traditional Chinese Medicine at 8 sites in China.
Trial summary
Chinese herbs can facilitate sputum culture conversion, promote lesion absorption, and enhance clinical symptoms and quality of life for patients with Mycobacterium abscessus pulmonary disease (MAB-PD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mycobacterium Abscessus Pulmonary Disease
- What is being tested?
- Chinese herbs-I and Chinese herbs-II
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 8 sitesChina
- Study dates
- 8 Sep 2025to Nov 2028
- Phase
- Phase 2
- 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
- Patient diagnosed with Mycobacterium abscessus pulmonary disease;
- Patients have completed the initial phase of treatment as recommended by the guidelines;
- Patients who have given written informed consent
- One week prior to enrollment, organ function levels must meet the following criteria: a. Hemoglobin ≥60g/L; b. Neutrophil count ≥0.5×10^9/L; c. Platelet count ≥60×10^9/L; d. Serum total bilirubin ≤3 times the upper limit of normal; e. Aspartate aminotransferase ≤3 times the upper limit of normal; f. Alanine aminotransferase ≤3 times the upper limit of normal; g. Creatinine level below 2 times the upper limit of normal or creatinine clearance ≥60mL/min; h. Urea nitrogen ≤200mg/L; i. Urinary protein <++, with ≥500mg total protein in 24-hour urine if protein is present; j. Blood glucose: within normal range and/or stable blood glucose control in diabetic patients; k. Cardiac function: no history of myocardial infarction within 6 months; no unstable angina; no severe arrhythmia.
Who cannot join
- Patients with a drug allergy to the investigational medication;
- Patients infected with two or more non-tuberculous mycobacteria, or those with active pulmonary tuberculosis;
- Patients with a prior history of pulmonary parenchymal organ transplantation;
- Patients with severe conditions such as congenital or acquired immunodeficiency disorders, active malignant tumors (primary or metastatic), or any malignancies requiring chemotherapy or radiotherapy during screening or study;
- Patients undergoing dialysis;
- Patients with radiation pneumonitis requiring corticosteroid or immunoglobulin pulse therapy, or clinically proven active interstitial lung disease, uncontrolled massive pleural effusion, or pericardial effusion;
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- Unstable systemic comorbidities (hypertensive crisis, unstable angina, congestive heart failure, myocardial infarction within the past 6 months, severe psychiatric disorders requiring medication, severe hepatic or renal dysfunction, neuropsychiatric conditions such as Alzheimer's disease);
- Patients with intestinal dysfunction or malabsorption syndrome;
- Pregnant or breastfeeding women;
- Patients receiving other investigational drugs within 4 weeks prior to first exposure to the study drug;
- Concurrent enrollment in another clinical trial, except for observational (non-interventional) studies or follow-up visits in interventional trials;
- Physical examinations or clinical tests that the investigator deems potentially interfering with results or increasing treatment-related complications.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Beijing Chest Hospital Affiliated to Capital Medical University
Beijing
Lihui Nie, +86010-89509342, nielihui666@sohu.com
- Not yet recruiting
China-Japan Friendship Hospital
Beijing
Xiaojing Cui, +86010-84205566, cuixiaojing86@163.com
- Recruiting
Guangzhou Municipal Hospital of Chest Medicine
Guangdong
Pinru Chen, +86020-87608724, Chenpinru1965@126.com
- Recruiting
Anhui Provincial Chest Hospital
Hefei
Hua Wang, +860551-63615363, 1726553540@qq.com
- Not yet recruiting
Jiangxi Chest Hospital
Nanchang
Fuchu Zhong, +860791-86766420, jhbzkzx@163.com
- Not yet recruiting
Fudan University Affiliated Huashan Hospital
Shanghai
Lingyun Shao, +86021-52889999, lingyun26@fudan.edu.cn
- Recruiting
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai
Zhenhui Lu, +86021-64385700-1307, tcmdoctorlu@163.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Jin Gu, +86021-65115006-2011, gujin51250@163.com
About this study
Official title: A Study to Assess the Traditional Chinese Medicine as Adjunctive Therapy to Improve Cure Rates During the Continuation Phase in Mycobacterium Abscessus Pulmonary Disease
Chinese herbs can facilitate sputum culture conversion, promote lesion absorption, and enhance clinical symptoms and quality of life for patients with Mycobacterium abscessus pulmonary disease (MAB-PD). The investigators aimed to evaluate the efficacy of Chinese herbs as adjunct therapy to improve cure rates or reduce recurrence rates during the continuation phase of MAB-PD treatment.
Read the detailed description
Mycobacterium abscessus pulmonary disease (MAB-PD) is a significant form of non-tuberculous mycobacterial lung infection that clinically presents with symptoms such as cough, sputum production, hemoptysis, low-grade fever, and chest tightness. Current guidelines recommend treatment regimens that are divided into initial and continuation phases. The initial phase involves combination therapy with at least three antibiotics, which can be administered intravenously or orally. In contrast, the continuation phase requires the use of oral or inhaled antibiotics. Guidelines suggest continuing treatment for 12 months after sputum culture negativity, although standard protocols indicate only a 35% cure rate with up to a 40% post-treatment relapse rate. Research has shown that traditional Chinese herbal formulas have broad immunomodulatory effects, which promote sputum culture conversion, lesion absorption, and improvement in clinical symptoms and quality of life for patients with MAB-PD. This study will enroll patients with MAB-PD who have completed initial treatment and will be divided into two independent randomized controlled trials (RCTs) based on sputum M.abscessus culture results. RCT-1 will include patients with persistently positive bacterial cultures receiving Chinese herbal therapy supplemented with the guideline-recommended regimen, with primary endpoints being 52-week cure rates. RCT-2 will include patients with negative bacterial cultures receiving Chinese herbal therapy supplemented with the guideline-recommended regimen, with primary endpoints being 52-week rates of relapse or reinfection. Patients will receive complimentary Chinese herbal medicine. All participants will undergo sputum or bronchoalveolar lavage fluid bacteriological testing, chest imaging, pulmonary function tests, a 6-minute walk test, SF-36, QOL-B, SGRQ, and HADS scales. Additionally, exploratory studies will collect sputum, bronchoalveolar lavage fluid, blood, and stool samples to identify the comprehensive immune profile of MAB-PD and evaluate the intervention advantages of traditional Chinese medicine.
- Being tested
- Chinese herbs-I, Chinese herbs-I placebo, Chinese herbs-II, Chinese herbs-II placebo
- Keywords
- Mycobacterium abscessus Pulmonary Disease, Continuation Phase, TCM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbs-IDrug
This is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease for a long time
Chinese herbs-I placeboDrug
Chinese herbs-I placebo
Chinese herbs-IIDrug
This is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease during the continuation phase for a long time
Chinese herbs-II placeboDrug
Chinese herbs-II placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group-I | Experimental | 104 participants with persistently positive bacterial cultures during the continuation phase received Chinese herbal therapy in addition to the guideline-recommended regimen, with the primary endpoint being the cure rates at 52 weeks. Receives: Drug: Chinese herbs-I |
| Control Group-I | Placebo comparator | 104 participants with persistently positive bacterial cultures during the continuation phase received a placebo comprising a 1/20 dose of Chinese herbs in addition to the guideline-recommended regimen, with the primary endpoint being the cure rates at 52 weeks. Receives: Drug: Chinese herbs-I placebo |
| Treatment Group-II | Experimental | 72 participants with negative bacterial cultures during the continuation phase received Chinese herbal therapy in addition to the guideline-recommended regimen, with the primary endpoint being the relapse or reinfection rates at 52 weeks. Receives: Drug: Chinese herbs-II |
| Control Group-II | Placebo comparator | 72 participants with negative bacterial cultures during the continuation phase received a placebo comprising a 1/20 dose of Chinese herbs in addition to the guideline-recommended regimen, with the primary endpoint being the relapse or reinfection rates at 52 weeks. Receives: Drug: Chinese herbs-II placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Measured the change from the Baseline to the end of treatment. The sputum MAB culture was negative on three consecutive occasions, with at least a one-month interval between each, and there were no subsequent positive results.
Measured: At the end of 52 weeks of treatment
Relapse or reinfection rates
Bacterial relapse is defined as the occurrence of at least two cultures and/or molecular biology tests identifying the same pathogenic M. abscessus strain as the initial infection after completing anti-M. abscessus treatment. When necessary, genotyping techniques may be employed to differentiate between relapse and reinfection. Reinfection refers to the emergence of different pathogenic strains or species in at least two positive cultures following the initiation of treatment.
Measured: At the end of 52 weeks of treatment
Secondary outcomes (9)
Time to sputum culture conversion
Measured the change from Baseline to the end of treatment
Measured: From baseline to 52 weeks post-treatment completion
Absorption rate of lung lesions
The lung lesion absorption rate is assessed via chest imaging to evaluate changes in pulmonary infection lesions compared to the baseline at 26 and 52 weeks after enrollment. Patients with more than half of their lesions absorbed are classified as showing significant absorption; those with less than half absorption are considered to have absorption; those with no changes are deemed to show no change; and those with enlarged lesions or new lesions are regarded as demonstrating deterioration. The determination of the lung lesion absorption rate is made by professional radiology experts.
Measured: Baseline, 26 weeks and 52 weeks
Rate of closure of lung cavities
The lung cavity closure rate is assessed through chest imaging to evaluate changes in lung cavities compared to the baseline at 26 and 52 weeks after enrollment. The clinical criteria for CT changes were as follows: Regarding changes in cavity size, scar healing, block healing, or disappearance were defined as closure. A reduction in cavity size by 1/2 or more was defined as reduction, a reduction in cavity diameter by less than 1/2 was classified as no change, and an increase in the cavity diameter by 1/2 or more was defined as increase.
The determination of the lung lesion absorption rate is made by professional radiology experts.
Measured: Baseline, 26 weeks and 52 weeks
Pulmonary function tests
Assess the patient's pulmonary function, specifically the changes in FEV1 (L), before treatment, as well as at 26 weeks and 52 weeks post-treatment
Measured: Baseline, 26 weeks and 52 weeks
6 minute walking test
Measured the change from Baseline to the end of treatment
Measured: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
36 - item Short Form (SF - 36)
The 36 - item Short Form (SF - 36) consists of 8 domains, namely physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. The SF - 36 scale ranges from 0 to 100 points, where higher scores signify better outcomes. The change from baseline to the end of treatment was measured at the indicated time.
Measured: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
Quality of Life Questionnaire for Bronchiectasis (QoL-B)
The Quality of Life Questionnaire for Bronchiectasis (QoL-B) encompasses eight dimensions: physical function, role function, vitality, emotion, social function, treatment effect, health perception, and respiratory symptoms. Each dimension is scored on a scale ranging from 0 to 100, where higher scores signify a better quality of life. The change from baseline to the end of treatment was measured at the indicated time.
Measured: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
Saint George's respiratory questionnaire (SGRQ)
The Saint George's Respiratory Questionnaire (SGRQ) scale comprises 50 questions, which assess three aspects: symptoms, activity, and disease impact. The calculation method is a weighted - average algorithm. The score of each item ranges from 0 to 100. The higher the score, the poorer the quality of life; the lower the score, the better the quality of life. The change from the baseline to the end of treatment was measured at the indicated time.
Measured: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
Hospital Anxiety and Depression Scale (HADS)
The HADS scale is employed to evaluate patients' anxiety and depression, with a total score ranging from 0 to 42 points. The anxiety sub - scale ranges from 0 to 21 points, and the depression sub - scale also ranges from 0 to 21 points. Higher scores signify a greater risk of anxiety or depression. The change from the baseline to the end of treatment was measured at the specified time.
Measured: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start8 Sep 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Abscessus 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants in the treatment group received the recommended treatment regimen according to guidelines, supplemented with Chinese herbs, upon study entry. In contrast, the control group received a placebo consisting of a 1/20 dose of Chinese herbs.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Anhui Chest Hospital, Guangzhou Chest Hospital., Jiangxi Chest Hospital, Beijing Chest Hospital, China-Japan Friendship Hospital, Huashan Hospital
- Responsible party
- Principal investigator, Zhenhui Lu, Shanghai University of Traditional Chinese Medicine
- Investigators
- Zhenhui Lu, Study chair, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295938
- Sponsor's protocol ID
- 2024LCSY166
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Traditional Chinese Medicine as Adjunctive Therapy to Improve Cure Rates During the Continuation Phase in Mycobacterium Abscessus Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07295938
- Acronym / sponsor ID
- 2024LCSY166
- Keywords
- Mycobacterium abscessus Pulmonary Disease, Continuation Phase, TCM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China, Anhui Chest Hospital, Guangzhou Chest Hospital., Jiangxi Chest Hospital, Beijing Chest Hospital, China-Japan Friendship Hospital, Huashan Hospital
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 22 Dec 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.
Chinese herbs can facilitate sputum culture conversion, promote lesion absorption, and enhance clinical symptoms and quality of life for patients with Mycobacterium abscessus pulmonary disease (MAB-PD). The investigators aimed to evaluate the efficacy of Chinese herbs as adjunct therapy to improve cure rates or reduce recurrence rates during the continuation phase of MAB-PD treatment.
Detailed description
Mycobacterium abscessus pulmonary disease (MAB-PD) is a significant form of non-tuberculous mycobacterial lung infection that clinically presents with symptoms such as cough, sputum production, hemoptysis, low-grade fever, and chest tightness. Current guidelines recommend treatment regimens that are divided into initial and continuation phases. The initial phase involves combination therapy with at least three antibiotics, which can be administered intravenously or orally. In contrast, the continuation phase requires the use of oral or inhaled antibiotics. Guidelines suggest continuing treatment for 12 months after sputum culture negativity, although standard protocols indicate only a 35% cure rate with up to a 40% post-treatment relapse rate. Research has shown that traditional Chinese herbal formulas have broad immunomodulatory effects, which promote sputum culture conversion, lesion absorption, and improvement in clinical symptoms and quality of life for patients with MAB-PD. This study will enroll patients with MAB-PD who have completed initial treatment and will be divided into two independent randomized controlled trials (RCTs) based on sputum M.abscessus culture results. RCT-1 will include patients with persistently positive bacterial cultures receiving Chinese herbal therapy supplemented with the guideline-recommended regimen, with primary endpoints being 52-week cure rates. RCT-2 will include patients with negative bacterial cultures receiving Chinese herbal therapy supplemented with the guideline-recommended regimen, with primary endpoints being 52-week rates of relapse or reinfection. Patients will receive complimentary Chinese herbal medicine. All participants will undergo sputum or bronchoalveolar lavage fluid bacteriological testing, chest imaging, pulmonary function tests, a 6-minute walk test, SF-36, QOL-B, SGRQ, and HADS scales. Additionally, exploratory studies will collect sputum, bronchoalveolar lavage fluid, blood, and stool samples to identify the comprehensive immune profile of MAB-PD and evaluate the intervention advantages of traditional Chinese medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- All participants in the treatment group received the recommended treatment regimen according to guidelines, supplemented with Chinese herbs, upon study entry. In contrast, the control group received a placebo consisting of a 1/20 dose of Chinese herbs.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group-I | Experimental | Drug: Chinese herbs-I104 participants with persistently positive bacterial cultures during the continuation phase received Chinese herbal therapy in addition to the guideline-recommended regimen, with the primary endpoint being the cure rates at 52 weeks. |
| Control Group-I | Placebo comparator | Drug: Chinese herbs-I placebo104 participants with persistently positive bacterial cultures during the continuation phase received a placebo comprising a 1/20 dose of Chinese herbs in addition to the guideline-recommended regimen, with the primary endpoint being the cure rates at 52 weeks. |
| Treatment Group-II | Experimental | Drug: Chinese herbs-II72 participants with negative bacterial cultures during the continuation phase received Chinese herbal therapy in addition to the guideline-recommended regimen, with the primary endpoint being the relapse or reinfection rates at 52 weeks. |
| Control Group-II | Placebo comparator | Drug: Chinese herbs-II placebo72 participants with negative bacterial cultures during the continuation phase received a placebo comprising a 1/20 dose of Chinese herbs in addition to the guideline-recommended regimen, with the primary endpoint being the relapse or reinfection rates at 52 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient diagnosed with Mycobacterium abscessus pulmonary disease;
- Patients have completed the initial phase of treatment as recommended by the guidelines;
- Patients who have given written informed consent
- One week prior to enrollment, organ function levels must meet the following criteria: a. Hemoglobin ≥60g/L; b. Neutrophil count ≥0.5×10^9/L; c. Platelet count ≥60×10^9/L; d. Serum total bilirubin ≤3 times the upper limit of normal; e. Aspartate aminotransferase ≤3 times the upper limit of normal; f. Alanine aminotransferase ≤3 times the upper limit of normal; g. Creatinine level below 2 times the upper limit of normal or creatinine clearance ≥60mL/min; h. Urea nitrogen ≤200mg/L; i. Urinary protein <++, with ≥500mg total protein in 24-hour urine if protein is present; j. Blood glucose: within normal range and/or stable blood glucose control in diabetic patients; k. Cardiac function: no history of myocardial infarction within 6 months; no unstable angina; no severe arrhythmia.
Key exclusion criteria (12 listed)
- Patients with a drug allergy to the investigational medication;
- Patients infected with two or more non-tuberculous mycobacteria, or those with active pulmonary tuberculosis;
- Patients with a prior history of pulmonary parenchymal organ transplantation;
- Patients with severe conditions such as congenital or acquired immunodeficiency disorders, active malignant tumors (primary or metastatic), or any malignancies requiring chemotherapy or radiotherapy during screening or study;
- Patients undergoing dialysis;
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 |
|---|---|---|
| Chinese herbs-IThis is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease for a long time | Drug | Treatment Group-I |
| Chinese herbs-I placeboChinese herbs-I placebo | Drug | Control Group-I |
| Chinese herbs-IIThis is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease during the continuation phase for a long time | Drug | Treatment Group-II |
| Chinese herbs-II placeboChinese herbs-II placebo | Drug | Control Group-II |
Primary outcome
Clinical cure rate
Time frame: At the end of 52 weeks of treatment
Measured the change from the Baseline to the end of treatment. The sputum MAB culture was negative on three consecutive occasions, with at least a one-month interval between each, and there were no subsequent positive results.
Relapse or reinfection rates
Time frame: At the end of 52 weeks of treatment
Bacterial relapse is defined as the occurrence of at least two cultures and/or molecular biology tests identifying the same pathogenic M. abscessus strain as the initial infection after completing anti-M. abscessus treatment. When necessary, genotyping techniques may be employed to differentiate between relapse and reinfection. Reinfection refers to the emergence of different pathogenic strains or species in at least two positive cultures following the initiation of treatment.
9 secondary outcomes
Time to sputum culture conversion
Time frame: From baseline to 52 weeks post-treatment completion
Absorption rate of lung lesions
Time frame: Baseline, 26 weeks and 52 weeks
Rate of closure of lung cavities
Time frame: Baseline, 26 weeks and 52 weeks
Pulmonary function tests
Time frame: Baseline, 26 weeks and 52 weeks
6 minute walking test
Time frame: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
36 - item Short Form (SF - 36)
Time frame: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
Quality of Life Questionnaire for Bronchiectasis (QoL-B)
Time frame: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
Saint George's respiratory questionnaire (SGRQ)
Time frame: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
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 22 Dec 2025.
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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.
Zhenhui Lu study chair
Longhua Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chinese herbs-I and Chinese herbs-II in people with Mycobacterium Abscessus Pulmonary Disease, run by Shanghai University of Traditional Chinese Medicine at 8 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 4 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shaoyan Zhang (+8621-64385700-1307, zhangshaoyan000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate (time frame: At the end of 52 weeks of treatment). The study lists 2 primary outcomes in all. 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 22 Dec 2025.