NCT04208581|UnknownPhase 3DMC
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Sponsor study identifier
interventional
372
1 country
1
Study Start
October 8, 2019
Actual (reported)Primary Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 8, 2019
Actual (reported)December 20, 2019
Actual (reported)December 23, 2019
Actual (reported)December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Clinical symptom assessment questionnaire
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
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)
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)
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
Change from baseline FEV1 at week 52 of the treatment phase, and week 52 of the follow-up phase.
Patients in this arm will receive Yiqi Huoxue Huatan granule in addition to Western medicine.
Patients in this arm will receive placebo Yiqi Huoxue Huatan granule in addition to Western medicine.
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.
Beijing Changping TCM Hospital
Beijing, China
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.
Suyun Li, Doctor
The First Affiliated Hospital of Henan University of Chinese Medicine
First Submitted
December 20, 2019
First Posted
December 23, 2019
Study Start
October 8, 2019
Actual (reported)Primary Completion
December 2021
Estimated (date passed)Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 7, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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