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| Name | Class |
|---|---|
| Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | OTHER |
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This study aims to establish the treatment scheme of Yiqi Huoxue Huatan granule for chronic obstructive pulmonary disease (COPD) with chronic respiratory failure (CRF), reducing mortality, improving quality of life and forming high quality evidence.
COPD is a highly prevalent disease, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in China. COPD has become the third leading cause of death worldwide. COPD complicated by CRF is serious and has a high mortality rate. At present, ideal and effective treatment is inadequate. Traditional Chinese medicine (TCM) has some potential in improving outcomes in COPD with CRF.
This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Yiqi Huoxue Huatan granule on reducing mortality and improving quality of life in COPD with CRF. After a 14-day run-in period, 372 subjects will be randomly assigned to treatment group or control group for 52-week treatment, followed by 52-week follow-up. The primary outcomes are all-cause mortality and frequency of acute exacerbation of COPD. The secondary outcomes include clinical symptoms, COPD assessment test (CAT), arterial blood gas analysis, pulmonary function and duration of mechanical ventilation. Safety will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yiqi Huoxue Huatan granule plus Western medicine | Experimental | Patients in this arm will receive Yiqi Huoxue Huatan granule in addition to Western medicine. |
|
| Placebo Yiqi Huoxue Huatan granule plus Western medicine | Placebo Comparator | Patients in this arm will receive placebo Yiqi Huoxue Huatan granule in addition to Western medicine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yiqi Huoxue Huatan granule | Drug | Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality will be calculated in this study. | Up to week 52 of the follow-up phase. |
| Frequency of acute exacerbation of COPD | Frequency of acute exacerbation of COPD will be recorded. | Up to week 52 of the follow-up phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical symptom assessment questionnaire | Clinical symptom assessment questionnaire of COPD will be used to assess symptoms. | Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase. |
| CAT |
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Inclusion Criteria:
A confirmed diagnosis of stable COPD;
Exclusion Criteria:
• CRF resulting from other respiratory diseases, such as bronchiectasis, pulmonary cystic fibrosis, lung cancer, etc.;
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| Name | Affiliation | Role |
|---|---|---|
| Suyun Li, Doctor | The First Affiliated Hospital of Henan University of Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Changping TCM Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40609812 | Derived | Yang JY, Wang HT, Zhao KM, Yu XQ, Huang DH, Wang HX, Wei GS, Bai L, Hou YJ, Huang QT, Hu J, Zhu HZ, Wu L, Lu XC, Chen YF, Gao F, Su LH, Wang Y, Li CY, Li SY, Feng CL. The efficacy and safety of Yiqi Huoxue Huatan granule in the treatment of stable COPD with chronic respiratory failure: A randomized, double-blind, placebo controlled trial. J Ethnopharmacol. 2025 Aug 29;352:120228. doi: 10.1016/j.jep.2025.120228. Epub 2025 Jul 1. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| D000068299 | Salmeterol Xinafoate |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| Placebo Yiqi Huoxue Huatan granule | Drug | Placebo Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks. |
|
|
COPD assessment test (CAT) will be used to assess quality of life. |
| Change from baseline CAT scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase. |
| Arterial partial pressure of oxygen (PaO2) | PaO2 will be evaluated by arterial blood gas analysis. | Change from baseline PaO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase. |
| Arterial partial pressure of carbon dioxide (PaCO2) | PaCO2 will be evaluated by arterial blood gas analysis. | Change from baseline PaCO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase. |
| FEV1 | Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function. | Change from baseline FEV1 at week 52 of the treatment phase, and week 52 of the follow-up phase. |
| Duration of mechanical ventilation | The duration of mechanical ventilation will be recorded. | Change from baseline duration of mechanical ventilation at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase. |
| Health economics | Cost of the treatment phase and follow-up phase will be recorded | Up to week 52 of the follow-up phase. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |