Traditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia

April 2, 2023 updated by: Zhenguo Zhai,MD,PhD, China-Japan Friendship Hospital

Traditional Chinese Medicine or Low-dose Dexamethasone in Symptomatic Patients With Post-COVID-19 Parenchymal Lung Abnormalities: a Randomized Controlled Trial Three Arm, Parallel Group, Single Blind, Randomized Controlled Trial.

The goal of this type of clinical trial is to learn about symptomatic patients with post-COVID-19 parenchymal lung abnormalities. The main questions it aims to answer are: the efficacy and safety of low-dose dexamethasone or traditional Chinese medicine in symptomatic patients with post-COVID-19 parenchymal lung abnormalities.

Participants will be divided into three parallel groups：controlled group with conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc. dexamethasone group: dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine. Chinese medicine group: Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of COVID-19 pneumonia；
  • 3 to 8 weeks after the onset of the first symptoms of COVID-19 infection;
  • Modified Medical Research Council (mMRC) score ⩾2 or hypoxemia;
  • Imaging severity assessment of pneumonia: CT severity scores (CTSS):≥5；
  • Signed the informed consent.

Exclusion Criteria:

  • Participants still admitted to intensive care unit at the time of enrollment;
  • Known prior structural lung disease, including pulmonary fibrosis, severe COPD, severe bronchiectasis, and lung destruction;
  • Taking glucocorticoids or immunosuppressants because of other chronic diseases;
  • Contraindications of glucocorticoid;
  • Heart failure(NYHA III or IV);
  • Participants with renal replacement therapy;
  • Psychiatric disorders or cognitive impairments;
  • The expected survival time is less than six months due to diseases other than COVID-19 pneumonia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: controlled group
conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc.
Other: conventional western medicine treatment
conventional western medicine treatment only
Experimental: dexamethasone group
dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine.
Other: conventional western medicine treatment
conventional western medicine treatment only
Drug: Dexamethasone oral tablet
treat with Dexamethasone for 2 weeks
Experimental: Chinese medicine group
Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.
Other: conventional western medicine treatment
conventional western medicine treatment only
Other: Traditional Chinese medicine decoction
treat with strengthening spleen and tonifying lung decoction for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung CT scan
Time Frame: 1 month
compared with base,≥90% pneumonia obsorbed
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung CT scan
Time Frame: 3 months
compared with base,≥50% pneumonia obsorbed
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Investigators

  • Principal Investigator: Zhenguo Zhai, Dcotor, Department of Respiratory and Critical Care Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 2, 2023

First Submitted That Met QC Criteria

April 2, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-ZF-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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