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A randomized controlled trial for Qingrejiedu and Buxiufeishen method combined with anti-tuberculosis drugs in the treatment of NTM lung disease

A randomized controlled trial for Qingrejiedu and Buxiufeishen method combined with anti-tuberculosis drugs in the treatment of NTM lung disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019887
Enrollment
Unknown
Registered
2018-12-07
Start date
2019-07-01
Completion date
Unknown
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nontuberculous mycobacteria

Interventions

Control group:anti-tuberculosis drugs
Experimental group:Tuberculosis drugs + kanglaogujin particles

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Comply with the diagnostic criteria of NTM lung disease, and confirmed that the pathogenic strain is Mycobacterium intracellulare or Mycobacterium abscessus by detecting the antigen mpd64, pmd medium and genetic test method of our laboratory; (2) Comply with the syndrome differentiation standard of Lung and Kidney Yin Deficiency and dominance of heat in the interior; (3) Chest CT examination revealed a hollow shadow or multiple lesions; (4) Aged 20 to 70 years old; (5) Those who are ineffective in regular anti-tuberculosis treatment; (6) Those who voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Those who do not meet the inclusion criteria; (2) Those with serious infections; (3) Patients with severe hypertension, coronary heart disease, cardiac insufficiency, and abnormal liver and kidney function; (4) Mental patients cannot cooperate with the treatment; (5) Pregnant or lactating women and those who are known to be allergic to the composition of the drug; (6) Patients who are participating in other drug clinical trials; (7) If the medication is not prescribed and the doctor's advice is not followed, and impossible to judge whether the curative effect or clinical data incompletely affects the curative effect;

Design outcomes

Primary

MeasureTime frame
sputum NTM culture conversion rate and recurrence rate;Lesion absorption;Cavity closure rate;TCM symptom score;TCM single symptom score;

Secondary

MeasureTime frame
Karnofsky score;Immune index;Blood routine;Biochemical Indicators;

Countries

China

Contacts

Public ContactLixin Wang

Shanghai Pulmonary Hospital

wlx1126@hotmail.com+86 18917962300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026