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Effects of Traditional Chinese Medicine on Bronchiectasis Patients

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ClinicalTrials.gov Identifier: NCT03443531
Recruitment Status : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Henan University of 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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Bufei Huatan granule Drug: Yifei Qinghua granule Drug: Placebo Bufei Huatan granule Drug: Placebo Yifei Qinghua granule Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Traditional Chinese Medicine on Bronchiectasis Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: TCM
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.
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.

Placebo Comparator: placebo TCM
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.
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.




Primary Outcome Measures :
  1. The frequency of bronchiectasis exacerbation [ 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. ]
    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 :
  1. The time to the first bronchiectasis exacerbation [ Time Frame: Week 24 of the treatment phase. ]
  2. Changes in Forced expiratory volume in one second [ 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. ]
    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 Outcome Measures:
  1. Changes in St Georges respiratory questionnaire scores [ 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. ]
    Using the St Georges respiratory questionnaire (SGRQ) to asses the impact of Bronchiectasis on a person's life.

  2. Changes in the Leicester Cough questionnaire scores [ 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. ]
    Using the Leicester Cough questionnaire (LCQ) to asses the impact of Bronchiectasis on a person's life.

  3. Changes in the Quality of Life-Bronchiectasis scores [ 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. ]
    Using the Quality of Life-Bronchiectasis (Qol-B) to asses the impact of Bronchiectasis on a person's life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443531


Contacts
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Contact: Zhiwan Wang, Doctor 86-0371-66248624 zhiwan_w@163.com
Contact: Yang Xie, Doctor 86-0371-66248624 xieyanghn@163.com

Sponsors and Collaborators
Henan University of Traditional Chinese Medicine
Investigators
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Study Chair: Jiansheng Li, Doctor Henan University of Traditional Chinese Medicine

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Responsible Party: Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03443531     History of Changes
Other Study ID Numbers: TCM for Bronchiectasis
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Henan University of Traditional Chinese Medicine:
Bronchiectasis
Traditional Chinese Medicine

Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases