Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure

NCT04208581 ↗

Phase 3 Unknown 372 enrolled Peking University People's Hospital Affiliated Hospital of Liaoning University of Traditional Chinese Medicine · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2019-10-08
Primary completion: 2021-12
Completion: 2021-12

Outcome

Mixed primary results

paper The primary outcomes were mortality and the frequency of acute exacerbations of COPD. PMID 40609812 ↗

paper treatment group compared to 20 (12.58 %, 95 % CI -7.37 %-17.79 %) in the control group, P = 0.131. PMID 40609812 ↗

paper frequency of acute exacerbations was significantly reduced in the follow-up period PMID 40609812 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Yiqi Huoxue Huatan granule	Traditional medicine (herbal / TCM)	—	—
Background	Budesonide	Small molecule	320 ug	Inhaled
Background	Fluticasone	Other / unclassified	250 ug	Inhaled
Background	Formoterol	Other / unclassified	4.5 ug	Inhaled
Background	Salmeterol	Other / unclassified	50 ug	Inhaled
Background	Tiotropium	Other / unclassified	18 ug	Inhaled