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Effects of Traditional Chinese Medicine on AECOPD Patients

Primary Purpose

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

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

TCM and conventional drug

TCM placebo and conventional drug

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Obstructive Pulmonary Disease, Acute exacerbation, Traditional Chinese medicine

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TCM plus conventional drug

TCM placebo plus conventional drug

Arm Description

The experimental group will receive three type of TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.

The control group will receive three type of placebo TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Treatment failure rate

Treatment success rate

Length of hospital stays

length hospital stays will be recorded.

Readmission due to AECOPD

Readmission due to AECOPD will be recorded.

Intubation rate

Intubation will be recorded.

Mortality

Dyspnea

Using modified Medical Research Council (mMRC) to asses the dyspnea of COPD, and how this changes over time.

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.

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.

Full Information

NCT ID

NCT03428412

First Posted

January 19, 2018

Last Updated

February 4, 2018

Sponsor

Henan University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03428412

Brief Title

Effects of Traditional Chinese Medicine on AECOPD Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2018 (Anticipated)

Primary Completion Date

September 30, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Henan University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Chronic Obstructive Pulmonary Disease, Acute exacerbation, Traditional Chinese medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

378 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TCM plus conventional drug

Arm Type

Experimental

Arm Description

Arm Title

TCM placebo plus conventional drug

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

TCM and conventional drug

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

TCM placebo and conventional drug

Intervention Description

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.

Primary Outcome Measure Information:

Title

COPD Assessment Test(CAT)

Description

Using COPD Assessment Test ( CAT) to asses the impact of AECOPD on a person's life, and how this changes over time.

Time Frame

Change from baseline CAT score at day 0, 14 of the treatment phase, at day 14, 28 of the follow-up phase.

Secondary Outcome Measure Information:

Title

Treatment failure rate

Time Frame

The numbers of treatment failure at day 14 of the treatment phase.

Title

Treatment success rate

Time Frame

The numbers of treatment success at day 14 of the treatment phase.

Title

Length of hospital stays

Description

length hospital stays will be recorded.

Time Frame

The length hospital stays in 14 Days of the treatment phase

Title

Readmission due to AECOPD

Description

Readmission due to AECOPD will be recorded.

Time Frame

The numbers of readmission due to AECOPD in 28 Days of the followup phase.

Title

Intubation rate

Description

Intubation will be recorded.

Time Frame

The numbers of intubation at day 4,7,10，14 of the treatment phase, at day 14, 28 of the follow-up phase.

Title

Mortality

Time Frame

The numbers of mortality at day 14 of the treatment phase and day 28 of the follow-up phase.

Title

Dyspnea

Description

Using modified Medical Research Council (mMRC) to asses the dyspnea of COPD, and how this changes over time.

Time Frame

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.

Title

SF-36

Description

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.

Time Frame

Change from Baseline in the SF-36 at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.

Title

COPD-PRO

Description

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.

Time Frame

Change from Baseline in the COPD-PRO at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hailong Zhang, doctor

Phone

86-371-66248624

zhanghailong6@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jiansheng Li, doctor

Phone

86-371-66248624

li_js8@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31842969

Citation

Zhang H, Li J, Yu X, Li S, Wang H, Ruan H, Si Y, Xie Y, Wang M. Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial. Trials. 2019 Dec 16;20(1):735. doi: 10.1186/s13063-019-3772-y.

Results Reference

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Effects of Traditional Chinese Medicine on AECOPD Patients

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