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TCM as an Adjuvant Treatment in Mycobacterium Abscessus Pulmonary Disease

NCT ID: NCT07295938

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-08

Study Completion Date

2028-11-30

Brief Summary

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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

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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.

Conditions

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Mycobacterium Abscessus Pulmonary Disease

Keywords

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Mycobacterium abscessus Pulmonary Disease Continuation Phase TCM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
This is a Double-blind Trial

Study Groups

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Treatment Group-I

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.

Group Type EXPERIMENTAL

Chinese herbs-I

Intervention Type DRUG

This is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease for a long time

Control Group-I

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.

Group Type PLACEBO_COMPARATOR

Chinese herbs-I placebo

Intervention Type DRUG

Chinese herbs-I placebo

Treatment Group-II

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.

Group Type EXPERIMENTAL

Chinese herbs-II

Intervention Type DRUG

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

Control Group-II

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.

Group Type PLACEBO_COMPARATOR

Chinese herbs-II placebo

Intervention Type DRUG

Chinese herbs-II placebo

Interventions

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Chinese herbs-I

This is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease for a long time

Intervention Type DRUG

Chinese herbs-I placebo

Chinese herbs-I placebo

Intervention Type DRUG

Chinese herbs-II

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

Intervention Type DRUG

Chinese herbs-II placebo

Chinese herbs-II placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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;
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role collaborator

Anhui Chest Hospital

OTHER

Sponsor Role collaborator

Guangzhou Chest Hospital.

UNKNOWN

Sponsor Role collaborator

Jiangxi Chest Hospital

UNKNOWN

Sponsor Role collaborator

Beijing Chest Hospital

OTHER

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zhenhui Lu

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhenhui Lu

Role: STUDY_CHAIR

Longhua Hospital

Locations

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Beijing Chest Hospital Affiliated to Capital Medical University

Beijing, , China

Site Status NOT_YET_RECRUITING

China-Japan Friendship Hospital

Beijing, , China

Site Status NOT_YET_RECRUITING

Guangzhou Municipal Hospital of Chest Medicine

Guangdong, , China

Site Status RECRUITING

Anhui Provincial Chest Hospital

Hefei, , China

Site Status RECRUITING

Jiangxi Chest Hospital

Nanchang, , China

Site Status NOT_YET_RECRUITING

Fudan University Affiliated Huashan Hospital

Shanghai, , China

Site Status NOT_YET_RECRUITING

Longhua Hospital Affiliated Shanghai University of TCM

Shanghai, , China

Site Status RECRUITING

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shaoyan Zhang

Role: CONTACT

Phone: +8621-64385700-1307

Email: [email protected]

Zhenhui Lu

Role: CONTACT

Phone: +8621-64385700-1307

Email: [email protected]

Facility Contacts

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Lihui Nie

Role: primary

Xiaojing Cui

Role: primary

Pinru Chen

Role: primary

Hua Wang

Role: primary

Fuchu Zhong

Role: primary

Lingyun Shao

Role: primary

Zhenhui Lu

Role: primary

Jin Gu

Role: primary

Other Identifiers

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2024LCSY166

Identifier Type: -

Identifier Source: org_study_id