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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03428412
Other study ID # TCM for AECOPD
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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