Effects of Traditional Chinese Medicine on Bronchiectasis Patients

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03443531
• Other study ID #: TCM for Bronchiectasis
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 26, 2018
• Last updated: February 17, 2018
• Start date: March 2018
• Est. completion date: December 2020

Study information

• Verified date: February 2018
• Source: Henan University of Traditional Chinese Medicine
• Contact: Zhiwan Wang, Doctor
• Phone: 86-0371-66248624
• Email: zhiwan_w[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in St Georges respiratory questionnaire scores	Using the St Georges respiratory questionnaire (SGRQ) to asses the impact of Bronchiectasis on a person's life.	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.
Other	Changes in the Leicester Cough questionnaire scores	Using the Leicester Cough questionnaire (LCQ) to asses the impact of Bronchiectasis on a person's life.	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.
Other	Changes in the Quality of Life-Bronchiectasis scores	Using the Quality of Life-Bronchiectasis (Qol-B) to asses the impact of Bronchiectasis on a person's life.	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.
Primary	The frequency of bronchiectasis exacerbation	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.	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.
Secondary	The time to the first bronchiectasis exacerbation		Week 24 of the treatment phase.
Secondary	Changes in Forced expiratory volume in one second	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.	Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.