NCT03443531

Effects of Traditional Chinese Medicine on Bronchiectasis Patients

Effects of Traditional Chinese Medicine on Bronchiectasis Patients: A Multi-center, Randomized, Double-blind, Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	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 Bufei Huatan granule, twice daily for 24 weeks for lower dosage.
DRUG	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 Yifei Qinghua granule, twice daily for 24 weeks for lower dosage.
DRUG	Placebo 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.
DRUG	Placebo 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.

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2018-02-23
• Last updated: 2018-02-23