Effect of Traditional Chinese Medicine on Outcomes in Patients With Severe / Very Severe COPD
A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Effectiveness of on Severe / Very Severe COPD Patients
1 other identifier
interventional
564
0 countries
N/A
Brief Summary
The aim of this study is to compare the effectiveness of two treatments for severe / very severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments and conventional medicine, which have been evaluated and have certain effect.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2014
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
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedOctober 21, 2014
October 1, 2014
2.2 years
October 17, 2014
October 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The frequency of exacerbation
Change from Baseline in the frequency of exacerbation at the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase
Secondary Outcomes (6)
Mortality
52 Weeks of the treatment phase and the 52 Weeks of the followup phase
Forced expiratory volume in one second
Change from Baseline in the one second (FEV1) at the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.
Dyspnea
Change from Baseline in MMRC at the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase
6 Minutes Walking Distance Test ( 6MWD)
Change from Baseline in the 6MWD at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.
Quality of life
Change from Baseline in the CAT, SF-36 and COPD-PRO at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.
- +1 more secondary outcomes
Study Arms (2)
Conventional medicine+ placebo TCM
EXPERIMENTALPatients in this group will be given conventional medicine, Salmeterol / fluticasone based on the classes of medications recommended by 2011 GOLD and Chinese Treatment Guidelines for COPD, and three placebo TCM treatment, which are which are placebo Bufeijianpi granule, placebo Bufeiyishen granule and placebo Yiqizishen granule corresponding to the three traditional Chinese syndromes in sequence, which are syndrome of deficiency of pulmono-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
conventional medicine+ TCM
EXPERIMENTALPatients in this group will receive Salmeterol / fluticasone based on the classes of medications recommended by 2011 GOLD and Chinese Treatment Guidelines for COPD, and three types of TCM treatment, which are Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule. A herbal extract twice daily for 52 weeks for lower dosage. The three granules are corresponding to the three traditional Chinese syndromes in sequence, which are syndrome of deficiency of pulmono-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
Interventions
According to the revised 2013 GOLD, Salmeterol / fluticasone was used to severe and very severe COPD patients for 52weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given Bufeijianpi granule, twice daily for 52 weeks for lower dosage.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bufeiyishen granule, twice daily for 52 weeks for lower dosage.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given placebo Bufeijianpi granule, twice daily for 52 weeks for lower dosage.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given placebo Bufeiyishen granule, twice daily for 52 weeks for lower dosage.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given placebo Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.
Eligibility Criteria
You may qualify if:
- A confirmed diagnosis of severe to very severe COPD.
- medically stable
- Age between 40 and 80 years.
- Syndrome differentiation belongs to syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
- with a two-week wash-out period prior to randomization
- Without participations in other interventional trials in the previous one month.
- With the informed consent signed.
You may not qualify if:
- Pregnant or breast-feeding women.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).
- Complicated with a neuromuscular disorder, which affected the respiration.
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
- Complicated with malignancy, congenital or acquired immune deficiency.
- Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
- Participating in other trials or allergic to the used medicine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Li J, Xie Y, Wang M, Li S, Yu X, Zhang N, Zhu Z, Zhang W, Feng J, Sun Z, Lin L, Sun Z, Zhang H, Yu X. Effect of traditional Chinese medicine combined with conventional Western medicine for patients with severe/very severe chronic obstructive pulmonary disease: a multi-center, randomized, double-blind, controlled study. Chin Med. 2025 May 20;20(1):66. doi: 10.1186/s13020-025-01117-x.
PMID: 40394700DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jiansheng Li, Doctor
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2014
First Posted
October 21, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
October 21, 2014
Record last verified: 2014-10