Clinical study on improving bronchiectasis with airflow limitation by Sufei Pingchuan Decoctio

Phase 1

• Conditions: Bronchiectasis

• Registration Number: ITMCTR2200005661
• Lead Sponsor: Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

( 1 ) Outpatients who meet the diagnostic criteria of bronchiectasis ; ( 2 ) Patients whose pulmonary function showed airflow limitation within 3 months before admission, and no acute exacerbation was found by medical history collection and physical examination ; ( 3 ) 18-70 years of age ; ( 4 ) TCM syndrome differentiation for lung and spleen qi deficiency, phlegm heat lung ; ( 5 ) Wish to comply with the physician 's diagnosis, treatment arrangements and sign an informed consent.

Exclusion Criteria

( 1 ) Patients with dry bronchiectasis characterized by hemoptysis ; ( 2 ) Patients who have experienced changes in their condition within 4 weeks before enrollment ; ( 3 ) Special bronchiectasis patients such as nontuberculous mycobacteria ( NTM ) and allergic bronchopulmonary aspergillosis ( ABPA ) ; ( 4 ) Patients who were allergic to tiotropium bromide or had drug contraindications ( such as narrow angle glaucoma, severe prostate hyperplasia, bladder neck stenosis and urinary retention ) ; ( 5 ) pregnant women or lactation women ; ( 6 ) chronic alcohol abuse history or drug abuse history or any factor affecting compliance ; ( 7 ) Those with serious heart, cerebrovascular, liver, kidney and hematopoietic system, peptic ulcer and other primary diseases ; ( 8 ) Abnormal liver and kidney function : liver ( ALT or AST ) more than double the upper limit of normal value or abnormal renal function ( BUN or Cr ) ; ( 9 ) Psychiatric patients ; ( 10 ) Having participated in other clinical trials within one month ; ( 11 ) Other situations that the researchers think are not suitable for inclusion.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FEV1;FEV1%pred;

Secondary Outcome Measures

Name	Time	Method
modified British medical research council;COPD assessment test;CRP;24 hours sputum volume;the Qualify of Life Questionnaire for Bronchiectasis;CASA-Q;MUC5AC;neutrophil elastase;chinese medicine syndrome scores;frequency of exacerbation;IL-6;NEUT%;TNF-a;