Effect of Yong Chong Cao Capsule on Outcomes in Patients With Mild to Severe COPD
NCT ID: NCT03745261
Last Updated: 2018-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
240 participants
INTERVENTIONAL
2018-06-20
2020-06-30
Brief Summary
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Detailed Description
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COPD, with high prevalence, morbidity, mortality and economic burdens, affects millions worldwide. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in placebo-controlled efficacy studies in highly selected populations. There are few clinical trials to compare therapeutic alternatives in real world. Furthermore, some randomized controlled trials on Yong Chong Cao capsule, one therapeutic type of Cordyceps sinensis in traditional Chinese medicine (TCM) interventions, especially based on the syndrome of insufficiency of qi of the lung and kidney patterns, have been the certain evidence for showing definite effect for COPD patients. In addition, studies in real world populations of COPD that received different cordyceps sinensis therapies that do have efficacy evidence was found wide variations in care delivery. In short, there is a need to compare the effectiveness of two capsule in patients with mild to severe COPD.
This is a multi-center, open-label, randomized, controlled study to evaluate the effectiveness of Yong Chong Cao capsule for patients with mild to severe COPD compared with Bailing capsule. Following a 14 day run-in period, approximately 240 subjects will be randomly assigned to Yong Chong Cao capsule treatment group, Bailing capsule treatment group for 24 weeks. After the 24 weeks treatment period, subjects in two treatments arms will follow-up 24 weeks. The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include FEV1, dyspnea (MMRC), exercise capacity(6MWD), quality of life (CAT, SGRQ). Safety will be assessed through the collection of adverse events. There will be a total of 4 study visits (baseline, the 12 and 24 weeks of the treatment, the 24 weeks of follow-up).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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YCC capsule+conventional medicine
Patients in this group will be given Yong Chong Cao (YCC) capsule and conventional medicine based on the classes of medications recommended by 2017 GOLD and Chinese Treatment Guidelines for COPD,which are Group A patients: Salbutamol (Ventolin®),Group B and Group C patients: Tiotropium Bromide (Spiriva®),Group D patients: Salmeterol / fluticasone (Seretide®).
Salbutamol (Ventolin®)
According to the revised 2017 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol will be used to Group A patients: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day.
Tiotropium Bromide (Spiriva®)
Tiotropium Bromide Powder for Inhalation will be used to Group B and Group C patients: Tiotropium Bromide Powder for Inhalation(Spiriva®, Boehringer Ingelheim), 18μg/ capsule, 10 capsules. 18μg each time, once daily.
Salmeterol / fluticasone (Seretide®)
Salmeterol / fluticasone will be used to Group D patients: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/250 μg / dose, 60 inhalations. 50/250 μg each time, twice daily.
YCC capsule
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Yong Chong Cao (YCC)capsule (Kecai®, Guangdong daguang pharmaceutical group Co., Ltd), 1 g each time, three times a day.
BL capsule + conventional medicine
Patients in this group will be given Bailing (BL) capsule and conventional medicine based on the classes of medications recommended by 2017 GOLD and Chinese Treatment Guidelines for COPD, which are Group A patients: Salbutamol (Ventolin®),Group B and Group C patients: Tiotropium Bromide (Spiriva®),Group D patients: Salmeterol / fluticasone (Seretide®).
Salbutamol (Ventolin®)
According to the revised 2017 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol will be used to Group A patients: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day.
Tiotropium Bromide (Spiriva®)
Tiotropium Bromide Powder for Inhalation will be used to Group B and Group C patients: Tiotropium Bromide Powder for Inhalation(Spiriva®, Boehringer Ingelheim), 18μg/ capsule, 10 capsules. 18μg each time, once daily.
Salmeterol / fluticasone (Seretide®)
Salmeterol / fluticasone will be used to Group D patients: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/250 μg / dose, 60 inhalations. 50/250 μg each time, twice daily.
BL capsule
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bailing(BL) capsule (Bailing®, Huadong Medicine Co.,Ltd), 1 g each time, three times a day
Interventions
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Salbutamol (Ventolin®)
According to the revised 2017 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol will be used to Group A patients: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day.
Tiotropium Bromide (Spiriva®)
Tiotropium Bromide Powder for Inhalation will be used to Group B and Group C patients: Tiotropium Bromide Powder for Inhalation(Spiriva®, Boehringer Ingelheim), 18μg/ capsule, 10 capsules. 18μg each time, once daily.
Salmeterol / fluticasone (Seretide®)
Salmeterol / fluticasone will be used to Group D patients: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/250 μg / dose, 60 inhalations. 50/250 μg each time, twice daily.
YCC capsule
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Yong Chong Cao (YCC)capsule (Kecai®, Guangdong daguang pharmaceutical group Co., Ltd), 1 g each time, three times a day.
BL capsule
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bailing(BL) capsule (Bailing®, Huadong Medicine Co.,Ltd), 1 g each time, three times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Medically stable.
* Syndrome differentiation belongs to syndrome of insufficiency of qi of the lung and kidney.
* Age between 18 and 80 years.
* With the informed consent signed.
Exclusion Criteria
* Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis, lung cancer).
* Complicated with heart failure (NYHA Class III or IV), or myocardial infarction within six months ,or unstable hemodynamics.
* Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
* Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
* Participating in other trials or allergic to the used medicine.
* Participating in other clinical trials with other interventions in one month.
* Allergic to the used medicine.
18 Years
80 Years
ALL
No
Sponsors
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Jiangsu Famous Medical Technology Co., Ltd.
INDUSTRY
Henan University of Traditional Chinese Medicine
OTHER
Responsible Party
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Principal Investigators
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Suyun Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of HUCM
Locations
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The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Yong Chong Cao for COPD
Identifier Type: -
Identifier Source: org_study_id
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