Effect of Yong Chong Cao Capsule on Outcomes in Patients With Mild to Severe COPD
A Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Effectiveness of Yong Chong Cao Capsule on Outcomes in Patients With Mild to Severe COPD
1 other identifier
interventional
240
1 country
1
Brief Summary
The aim of this study is to evaluate the effectiveness of Yong Chong Cao capsule on outcomes in patients with mild to severe Chronic Obstructive Pulmonary Disease (COPD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2018
CompletedFirst Submitted
Initial submission to the registry
November 15, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedNovember 19, 2018
November 1, 2018
1.4 years
November 15, 2018
November 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The frequency of exacerbation of COPD
The exacerbation of COPD often results in reduced quality of life, increased rate of lung function decline, increased hospitalization. It is important to assess the changes of 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 Outcomes (6)
Changes in Modified Medical Research Council scale scores
Changes in the mMRC scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in Forced expiratory volume in one second
Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.
Changes in COPD Assessment Test scores
Changes in the CAT scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in Six Minutes Walking Distance
Changes in the 6WMD scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in St Georges respiratory questionnaire scores
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.
- +1 more secondary outcomes
Study Arms (2)
YCC capsule+conventional medicine
EXPERIMENTALPatients 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®).
BL capsule + conventional medicine
EXPERIMENTALPatients 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®).
Interventions
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 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 will be used to Group D patients: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/250 μg / dose, 60 inhalations. 50/250 μg each time, twice daily.
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.
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
Eligibility Criteria
You may qualify if:
- A confirmed diagnosis of mild to severe COPD.
- 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.
You may not qualify if:
- Pregnant or breast-feeding women.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000, China
Related Publications (1)
Li S, Xie Y, Lin L, Wu L, Yu X, Ma Z, Yin Q. The Effectiveness of Yong Chong Cao Capsule in Patients With Mild to Severe COPD: A Multi-Center, Randomized, Active-Controlled Trial. J Evid Based Med. 2025 Dec;18(4):e70091. doi: 10.1111/jebm.70091. Epub 2025 Nov 26.
PMID: 41295088DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suyun Li, Doctor
The First Affiliated Hospital of HUCM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2018
First Posted
November 19, 2018
Study Start
June 20, 2018
Primary Completion
December 1, 2019
Study Completion
June 1, 2020
Last Updated
November 19, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share