Bronchiectasis
Conditions
Keywords
Bronchiectasis, Traditional Chinese Medicine
Brief summary
The aim of this study is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) on patients with clinically stable bronchiectasis by a multi-center, randomized, double-blind, controlled trial: one, TCM treatments based on syndrome differentiation; the other, a placebo of TCM treatment.
Detailed description
Bronchiectasis is a common and frequently occurring respiratory disease, with more hospitalization rate and mortality, poor quality of life and heavy financial burden. The main clinical manifestations are persistent or recurrent cough, expectoration, sometimes accompanied by hemoptysis, which can cause respiratory dysfunction and chronic pulmonary heart disease. There are some randomized controlled trials of TCM for bronchiectasis, and have the effect in the treatment of bronchiectasis, reducing the number of acute aggravation and alleviating dyspnea. However, some TCM interventions lack comprehensive syndrome differentiation and the placebo control. This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy to evaluate the effectiveness of TCM on patients with clinically stable bronchiectasis. 216 subjects will be randomly assigned to one therapies (TCM treatments based on syndrome differentiation) and the other therapy (placebo of TCM treatment) for 24 weeks. After the treatment period, the subjects will be followed up for 24 weeks. The primary outcomes include the frequency of bronchiectasis exacerbation, and the secondary outcomes include quality of life (SGRQ, LCQ, QOL-B), pulmonary function, safety observation index.
Interventions
DRUGBufei Huatan granule
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung will be given Bufei Huatan granule, twice daily for 24 weeks for lower dosage.
DRUGYifei Qinghua granule
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung will be given Yifei Qinghua granule, twice daily for 24 weeks for lower dosage.
DRUGPlacebo Bufei Huatan granule
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung will be given placebo Bufei Huatan granule, twice daily for 24 weeks for lower dosage.
DRUGPlacebo Yifei Qinghua granule
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung will be given placebo Yifei Qinghua granule, twice daily for 24 weeks for lower dosage.
Sponsors
Henan University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* A confirmed diagnosis of clinically stable bronchiectasis * Age between 18 and 80 years * Syndrome differentiation meets criteria of syndrome of Qi deficiency of lung and phlegm-turbidity obstructing the lung, syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung * Without participations in other interventional trials in the previous one month * With the informed consent signed
Exclusion criteria
* Current respiratory disorders other than bronchiectasis (e.g. COPD,bronchial asthma, lung cancer,active tuberculosis, Interstitial lung disease, pulmonary thromboembolic, or Other patients who have an impact on the observation of disease) * Patients with severe cardiovascular disease (e.g. Acute myocardial infarction,Acute heart failure) * Severe liver disease(e.g.Active phase of hepatitis, Cirrhosis, Severe impairment of liver function by portal hypertension) * Severe renal disease(e.g. renal transplant, dialysis) * Patients with large hemoptysis in the last month * Pregnant and lactating women * Insanity, Dementia, and all kinds of Psychosis * Smoking patients (Years of smoking10/ package year) * Participating in other clinical trials with other interventions; * Allergic to the used medicine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The frequency of bronchiectasis exacerbation | Changes in the frequency of exacerbation at the week 12 and week 24 of the treatment phase, and at the week 24 of the follow-up phase compared with baseline. | The bronchiectasis exacerbations often result in reduced quality of life, increased rate of lung function decline, increased hospitalization. It is important to assess the changes of bronchiectasis exacerbations over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The time to the first bronchiectasis exacerbation | Week 24 of the treatment phase. | — |
| Changes in Forced expiratory volume in one second | Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline. | Forced expiratory volume in one second (FEV1)is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in St Georges respiratory questionnaire scores | Changes in the SGRQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline. | Using the St Georges respiratory questionnaire (SGRQ) to asses the impact of Bronchiectasis on a person's life. |
| Changes in the Leicester Cough questionnaire scores | Changes in the LCQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline. | Using the Leicester Cough questionnaire (LCQ) to asses the impact of Bronchiectasis on a person's life. |
| Changes in the Quality of Life-Bronchiectasis scores | Changes in the Qol-B scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline. | Using the Quality of Life-Bronchiectasis (Qol-B) to asses the impact of Bronchiectasis on a person's life. |
Contacts
Primary ContactZhiwan Wang, Doctor
Backup ContactYang Xie, Doctor
Outcome results
None listed