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

NCT04851093 | Unknown DMC

• 1 other identifier: TCM for AECOPD Risk Window
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Acute Exacerbation Risk Window; Traditional Chinese Medicine; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Acute exacerbation rate in the AECOPD Risk Window

  The numbers of acute exacerbation in the AECOPD Risk Window will be recorded.

  in 8 weeks of the treatment period.

• COPD Assessment Test (CAT) in the AECOPD Risk Window

  The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life. It is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact).

  Change from baseline CAT scores at week 0, 8 of the treatment period.

Secondary Outcomes (11)

• Time to the first acute exacerbation

  up to week 26 during the study period.

• Degree of acute exacerbation in the AECOPD Risk Window

  in 8 weeks of the treatment period.

• Acute exacerbation rate in the follow-up period

  in 18 weeks of the follow-up period.

• Degree of acute exacerbation in the follow-up period

  in 18 weeks of the follow-up period.

• COPD Assessment Test (CAT) in the follow-up period

  Change from baseline CAT scores at week 16, 26 of the follow-up period.

Study Arms (2)

TCM granule plus conventional drug

EXPERIMENTAL

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.

Drug: TCM granule plus conventional drug

TCM placebo granule plus conventional drug

PLACEBO COMPARATOR

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.

Drug: TCM placebo granule plus conventional drug

Interventions

TCM granule plus conventional drug 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 granule plus conventional drug

TCM placebo granule plus conventional drug 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.

TCM placebo granule plus conventional drug

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A confirmed diagnosis of AECOPD Risk Window;
• Age ranges from 40 years to 80 years;
• 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;
• Without participations in other interventional trials in the previous one month;
• With the informed consent signed.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiansheng Li, doctor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Hailong Zhang, doctor

CONTACT

+86-0371-66248624; zhanghailong6@126.com

Jiansheng Li, doctor

CONTACT

+86-0371-66248624; li_js8@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 20, 2021
• Study Start: March 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

CN (1)