Status:

UNKNOWN

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

Lead Sponsor:

Henan University of Traditional Chinese Medicine

Conditions:

Chronic Obstructive Pulmonary Disease

Eligibility:

All Genders

40-80 years

Phase:

NA

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 ...

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 h...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

March 15 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2022

Estimated Enrollment :

336 Patients enrolled

Trial Details

Trial ID

NCT04851093

Start Date

March 15 2021

End Date

December 31 2022

Last Update

April 20 2021

Active Locations (1)

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1

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China, 450000