Effects of Traditional Chinese Medicine on AECOPD Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03428412
• Other study ID #: TCM for AECOPD
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 19, 2018
• Last updated: February 4, 2018
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2018
• Source: Henan University of Traditional Chinese Medicine
• Contact: Hailong Zhang, doctor
• Phone: 86-371-66248624
• Email: zhanghailong6[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 378
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• A confirmed diagnosis of moderate to very severe AECOPD

• Age between 40 and 80 years

• Syndrome differentiation meets criteria of syndrome of external cold and internal fluid,syndrome of phlegm-heat congesting lung,or syndrome of phlegm-damp amassing in lung

• Without participations in other interventional trials in the previous one month

• With the informed consent signed

Exclusion Criteria:

• Pregnant and lactating women

• Dementia, mental disorders and reluctant partners

• Complicated with heart failure (NYHA Class IV), or Serious cardiac arrhythmias, or unstable hemodynamics

• Current respiratory disorders other than COPD (e.g., bronchiectasis, active tuberculosis, pneumothorax, Pleural effusion, pulmonary thromboembolic, or Neuromuscular diseases affect respiratory movement function)

• Combined tumor

• Treated outside the hospital for more than 7 days

• Need to carry out invasive mechanical ventilation respiratory failure

• Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation)

• Bedridden for various reasons

• Allergic to the used medicine

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD Assessment Test(CAT)	Using COPD Assessment Test ( CAT) to asses the impact of AECOPD on a person's life, and how this changes over time.	Change from baseline CAT score at day 0, 14 of the treatment phase, at day 14, 28 of the follow-up phase.
Secondary	Treatment failure rate		The numbers of treatment failure at day 14 of the treatment phase.
Secondary	Treatment success rate		The numbers of treatment success at day 14 of the treatment phase.
Secondary	Length of hospital stays	length hospital stays will be recorded.	The length hospital stays in 14 Days of the treatment phase
Secondary	Readmission due to AECOPD	Readmission due to AECOPD will be recorded.	The numbers of readmission due to AECOPD in 28 Days of the followup phase.
Secondary	Intubation rate	Intubation will be recorded.	The numbers of intubation at day 4,7,10,14 of the treatment phase, at day 14, 28 of the follow-up phase.
Secondary	Mortality		The numbers of mortality at day 14 of the treatment phase and day 28 of the follow-up phase.
Secondary	Dyspnea	Using modified Medical Research Council (mMRC) to asses the dyspnea of COPD, and how this changes over time.	Change from Baseline in the mMRC at day 0, 4, 7, 10,14 of the treatment phase, at day 14, 28 of the follow-up phase.
Secondary	SF-36	Using the MOS item short from health survey (SF-36) to asses the impact of COPD on a person's life, and how this changes over time.	Change from Baseline in the SF-36 at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.
Secondary	COPD-PRO	Using the COPD patient reported outcome scale (COPD-PRO) to asses the impact of COPD on a person's life, and how this changes over time.	Change from Baseline in the COPD-PRO at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.