A Randomized Double-blind Controlled Study of Sequential Treatment of Traditional Chinese Medicine for Bronchodilatation Secondary to MDR-PA Colonizatio

Phase 1

• Conditions: Bronchiectasis

• Registration Number: ITMCTR2000003365
• Lead Sponsor: onghua Hospital Shanghai University of Traditional Chinese Medicine

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

Test 1: Sang Baipi Decoction loaded with azithromycin in the treatment of bronchiectasis phlegm heat accumulation lung syndrome clinical study
1. Patients who meet the diagnostic criteria for bronchiectasis;
2. It meets the diagnostic criteria of traditional Chinese medicine for phlegm-heat accumulation lung syndrome;
3. The age range is between 18-70 years old;
4. Voluntarily accept the treatment plan and sign an informed consent form.
Trial 2: Clinical Study of Baozhen Decoction for Sequential Treatment of Bronchodilator Qi and Yin Deficiency Syndrome
1. Complete the trial 1 Sang Baipi Tang interventional treatment and meet the two syndromes of qi and yin deficiency,
Or it has not been treated with traditional Chinese medicine but meets the diagnostic criteria for qi and yin deficiency syndrome;
2. The age range is between 18-70 years old;
3. Voluntarily accept the treatment plan and sign an informed consent form.

Exclusion Criteria

Test 1: Sang Baipi Decoction loaded with azithromycin in the treatment of bronchiectasis phlegm heat accumulation lung syndrome clinical study
1. Known allergy to Chinese medicine or azithromycin;
2. Secondary or primary liver and kidney damage is not cured;
3. Patients with diabetes or severe primary diseases such as cardiovascular and cerebrovascular, kidney, lung, and hematopoietic systems;
4. Those with severe cardiopulmonary insufficiency;
5. Patients who are pregnant or lactating;
6. Those with a history of mental illness that is difficult to control;
7. Those who cannot take traditional Chinese medicine due to diseases such as fasting due to gastrointestinal bleeding
Trial 2: Clinical Study of Baozhen Decoction for Sequential Treatment of Bronchodilator Qi and Yin Deficiency Syndrome
1. Those who are known to be allergic to traditional Chinese medicine;
2. Secondary or primary liver and kidney damage is not cured;
3. Patients with diabetes or severe primary diseases such as cardiovascular and cerebrovascular, kidney, lung, and hematopoietic systems;
4. Those with severe cardiopulmonary insufficiency;
5. Patients who are pregnant or lactating;
6. Those with a history of mental illness that is difficult to control;
7. Those who cannot take traditional Chinese medicine due to diseases such as fasting due to gastrointestinal bleeding

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Chest CT;TCM syndrome points;Sputum bacteria conversion rate;

Secondary Outcome Measures

Name	Time	Method
umber of acute exacerbations;Lung function;