Back to resultsEffects of Traditional Chinese Medicine on Bronchiectasis Patients
Primary Purpose
Bronchiectasis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bufei Huatan granule
Yifei Qinghua granule
Placebo Bufei Huatan granule
Placebo Yifei Qinghua granule
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis, Traditional Chinese Medicine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TCM
placebo TCM
Arm Description
Patients in this group will receive two types of TCM treatment, which are Bufei Huatan granule, Yifei Qinghua granule. The herbal extract twice daily for 24 weeks for lower dosage. The two granules are corresponding to the two traditional Chinese syndromes in sequence, which are syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung, Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung.
Patients in this group will be given two placebo TCM treatment, which are which are placebo Bufei Huatan granule, placebo Yifei Qinghua granule, corresponding to the two traditional Chinese syndromes in sequence, which are syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung, Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The time to the first bronchiectasis exacerbation
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.
Full Information
NCT ID
NCT03443531
First Posted
January 26, 2018
Last Updated
February 17, 2018
Sponsor
Henan University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03443531
Brief Title
Effects of Traditional Chinese Medicine on Bronchiectasis Patients
Official Title
Effects of Traditional Chinese Medicine on Bronchiectasis Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, Traditional Chinese Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TCM
Arm Type
Experimental
Arm Description
Patients in this group will receive two types of TCM treatment, which are Bufei Huatan granule, Yifei Qinghua granule. The herbal extract twice daily for 24 weeks for lower dosage. The two granules are corresponding to the two traditional Chinese syndromes in sequence, which are syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung, Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung.
Arm Title
placebo TCM
Arm Type
Placebo Comparator
Arm Description
Patients in this group will be given two placebo TCM treatment, which are which are placebo Bufei Huatan granule, placebo Yifei Qinghua granule, corresponding to the two traditional Chinese syndromes in sequence, which are syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung, Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung.
Intervention Type
Drug
Intervention Name(s)
Bufei Huatan granule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Yifei Qinghua granule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Bufei Huatan granule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Yifei Qinghua granule
Intervention Description
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.
Primary Outcome Measure Information:
Title
The frequency of bronchiectasis exacerbation
Description
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.
Time Frame
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 Outcome Measure Information:
Title
The time to the first bronchiectasis exacerbation
Time Frame
Week 24 of the treatment phase.
Title
Changes in Forced expiratory volume in one second
Description
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.
Time Frame
Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.
Other Pre-specified Outcome Measures:
Title
Changes in St Georges respiratory questionnaire scores
Description
Using the St Georges respiratory questionnaire (SGRQ) to asses the impact of Bronchiectasis on a person's life.
Time Frame
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.
Title
Changes in the Leicester Cough questionnaire scores
Description
Using the Leicester Cough questionnaire (LCQ) to asses the impact of Bronchiectasis on a person's life.
Time Frame
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.
Title
Changes in the Quality of Life-Bronchiectasis scores
Description
Using the Quality of Life-Bronchiectasis (Qol-B) to asses the impact of Bronchiectasis on a person's life.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiwan Wang, Doctor
Phone
86-0371-66248624
Email
zhiwan_w@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Xie, Doctor
Phone
86-0371-66248624
Email
xieyanghn@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiansheng Li, Doctor
Organizational Affiliation
Henan University of Traditional Chinese Medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Traditional Chinese Medicine on Bronchiectasis Patients
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