NCT03428412

Effects of Traditional Chinese Medicine on AECOPD Patients

Effects of Traditional Chinese Medicine on AECOPD Patients: A Multi-center, Randomized, Double-blind, Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 14 days treatment. After the treatment period, subjects in two arms will be followed up for 4 weeks. The primary outcomes will include COPD Assessment Test (CAT), and secondary outcomes include treatment failure rate, treatment success rate, hospitalization time, hospital admission rate, endotracheal intubation rate, mortality and quality of life (COPD-PRO, SF-36).

Conditions

• Pulmonary Disease, Chronic Obstructive
• Acute Exacerbation
• Medicine, Chinese Traditional

Interventions

Type	Name	Description
DRUG	TCM and conventional drug	All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD. The Experimental group will receive TCM according to the TCM syndrome. Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days. Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days. Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days.
DRUG	TCM placebo and conventional drug	All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD. The control group will receive TCM placebo according to the TCM syndrome. Placebo Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days. Placebo Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days. Placebo Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-09-30
• Completion: 2019-12-31
• First posted: 2018-02-09
• Last updated: 2018-02-09