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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)

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)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005886
Enrollment
Unknown
Registered
2022-04-18
Start date
2022-05-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Bronchiectasis

Interventions

observation group:Bupi Qingfei Prescription granules
control group:Bupi Qingfei formula granule simulation agent

Sponsors

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
the Qualify of Life Questionnaire for Bronchiectasis;the number of exacerbations;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactMiao Qing
miaoqing55@sina.com13910812309

Outcome results

None listed

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