Effects of Traditional Chinese Medicine on Outcomes in Patients With AECOPD Risk Window

NCT ID: NCT04851093

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2022-12-31

Brief Summary

This study aims to objectively evaluate the clinical efficacy and safety of Traditional Chinese Medicine in the treatment of AECOPD Risk Window, providing a basis for the formulation of TCM treatment plan with AECOPD.

Detailed Description

The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in China. COPD has become the third leading cause of death worldwide. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, readmission, and disease progression.

Due to the non-random and non-accidental occurrence of AECOPD，with acute exacerbations occurring mainly in a centralized period after an acute exacerbation, and wide open to attack easily in this period, we call this "highly dangerous period" as "AECOPD Risk Window". The AECOPD Risk Window has persistent systemic inflammation and unstable lung function, which increases the risk of AECOPD recurrence and readmission.

At present, western medicine has relatively mature treatment measures for COPD at the acute exacerbation stage and stable stage, however, there is no specific guidance on the medication of AECOPD Risk Window. COPD have been effectively treated with Chinese medicine for a long time. The study of syndrome regularity of "AECOPD Risk Window" provides a basis for the formulation of syndrome differentiation plan.

This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD Risk Window. 336 subjects will be randomly assigned in a 1:1 ratio to experimental group or control group for 8 weeks treatment and 18 weeks follow-up. On the basis of health education and conventional treatment, the experimental group will receive TCM granule according to the TCM syndrome, while the control group will receive TCM placebo granule according to the TCM syndrom. The primary outcomes are acute exacerbation rate in the AECOPD Risk Window, COPD Assessment Test (CAT) in the AECOPD Risk Window; and secondary outcomes are time to the first acute exacerbation, degree of acute exacerbation in the AECOPD Risk Window, acute exacerbation rate in the follow-up period, degree of acute exacerbation in the follow-up period, COPD Assessment Test (CAT) in the follow-up period, lung function, clinical symptom scores, mMRC, quality of life and index of security.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TCM granule plus conventional drug

The experimental group will receive three types of TCM granule and conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.

Group Type: EXPERIMENTAL

TCM granule plus conventional drug

Intervention Type: DRUG

All patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.

Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome.

Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome.

Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome.

TCM granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks.

TCM placebo granule plus conventional drug

The control group will receive three types of TCM placebo granule and conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.

Group Type: PLACEBO_COMPARATOR

TCM placebo granule plus conventional drug

Intervention Type: DRUG

All patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.

Placebo Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome.

Placebo Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome.

Placebo Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome.

TCM placebo granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks.

The appearance, weight, color and odor of the preparation are the same as those of experimental group.

The placebo granule consists of dextrin, bitter and 5% of the TCM granule.

Interventions

TCM granule plus conventional drug

All patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.

Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome.

Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome.

Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome.

TCM granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks.

Intervention Type: DRUG

TCM placebo granule plus conventional drug

All patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.

Placebo Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome.

Placebo Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome.

Placebo Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome.

TCM placebo granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks.

The appearance, weight, color and odor of the preparation are the same as those of experimental group.

The placebo granule consists of dextrin, bitter and 5% of the TCM granule.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. A confirmed diagnosis of AECOPD Risk Window;

2. Age ranges from 40 years to 80 years;

3. Syndrome differentiation meets criteria of qi deficiency and internal cold fluid syndrome, qi and yin deficiency and unclean phlegm heat syndrome, or lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome;

4. Without participations in other interventional trials in the previous one month;

5. With the informed consent signed.

Exclusion Criteria

1. Pregnant and lactating women;

2. Dementia, mental disorders and reluctant partners;

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

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

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

6. Bedridden for various reasons;

7. Allergic to the used medicine.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiansheng Li, doctor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Locations

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hailong Zhang, doctor

Role: CONTACT

zhanghailong6@126.com

+86-0371-66248624

Jiansheng Li, doctor

Role: CONTACT

li_js8@163.com

+86-0371-66248624

Facility Contacts

Hailong Zhang, doctor

Role: primary

zhanghailong6@126.com

+86-0371-66248624

Other Identifiers

TCM for AECOPD Risk Window

Identifier Type: -

Identifier Source: org_study_id