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A multicenter randomized, double-blind placebo-controlled study of invigorating spleen and Clearing Lung in the treatment of bronchiectasis (spleen deficiency and lung heat syndrome)

Phase 1
Conditions
Bronchiectasis
Registration Number
ITMCTR2200005886
Lead Sponsor
Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1.Outpatients meeting the diagnostic criteria for stable bronchiectasis; 2. Aged 18-70; 3. TCM syndrome differentiation is lung qi deficiency phlegm heat accumulation of lung; 4 patients with at least one exacerbation in the past 1 year; 5. Those who are willing to comply with the doctor's diagnosis and treatment arrangement and sign the informed consent.

Exclusion Criteria

1.With hemoptysis as the main manifestation of dry bronchioma patients; 2.Patients with pulmonary interstitial fibrosis resulting in tractive bronchiectasis; 3.Patients with active pulmonary tuberculosis and pulmonary fungal infection; 4.Pregnant women or lactating women; 5.History of chronic alcohol or substance abuse or any factors affecting compliance;6.Poor compliance during screening; 7.Complicated with primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system; 8.abnormal liver and kidney function: liver (ALT or AST) more than twice the upper limit of normal value or abnormal kidney function (BUN or Cr); 9.mental patients; 10. allergic constitution and allergic to this drug; 11.Participated in other clinical trials within 1 month; 12.Other conditions that the investigator considers inappropriate for inclusion.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
the Qualify of Life Questionnaire for Bronchiectasis;the number of exacerbations;
Secondary Outcome Measures
NameTimeMethod
neutrophil elastase;hepatic and renal function;TNF-a;TCM syndrome integral;IL-8;FEV1\FEV1%pred\FVC\FVC%pred\FEV1/FVC;intestinal flora;Th17;CD8+;NEUT%;CD4+;Treg17;IL-6;mMRC;
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