Tongsai granule for syndrome of phlegm heat obstructing lung in acute exacerbation of chronic obstructive pulmonary disease: a pilot study

Phase 1

Recruiting

Conditions: chronic obstructive pulmonary disease

Registration Number: ITMCTR2100004303

Lead Sponsor: The First Affiliated Hospital of He'nan University of Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(1) Patients who are diagnosed with moderate to severe AECOPD;
(2) Patients who meet the Chinese medicine syndrome classification of phlegm heat obstructing lung;
(3) Patients who are aged 40–80 years;
(4) Patients who do not participate in other interventional trials in the past month;
(5) Patients who sign the written informed consent form.

Exclusion Criteria

(1) Patients who are pregnant or lactating;
(2) Patients who are unable to communicate;
(3) Patients who have heart failure (NYHA Class IV), severe cardiac arrhythmias,or unstable hemodynamics;
(4) Patients who have bronchiectasis, active tuberculosis, pneumothorax, pleural effusion, pulmonary thromboembolic, or neuromuscular diseases affecting respiratory movement function;
(5) Patients who have a history of tumor;
(6) Patients who have been treated for more than seven days outside the hospital;
(7) Patients who require invasive mechanical ventilation;
(8) Patients who have severe liver or kidney disease;
(9) Patients who require long-term bed rest;
(10) Patients who have known hypersensitivity to the study medication or some of its ingredients.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration from admission to the time meeting discharge criteria;Clinical COPD questionnaire (CCQ);

Secondary Outcome Measures

Name	Time	Method
Clinical symptoms and signs scores;Arterial blood gas analysis;Frequency and severity of acute exacerbation;mMRC;mESQ-COPD;The time to the first acute exacerbation;COPD assessment test (CAT);mPRO-COPD;