Back to resultsTraditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia
Primary Purpose
COVID-19 Pneumonia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
conventional western medicine treatment
Dexamethasone oral tablet
Traditional Chinese medicine decoction
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
Eligibility Criteria
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.
Sites / Locations
- China-Japan Friendship HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
controlled group
dexamethasone group
Chinese medicine group
Arm Description
conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc.
dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine.
Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.
Outcomes
Primary Outcome Measures
Lung CT scan
compared with base,≥90% pneumonia obsorbed
Secondary Outcome Measures
Lung CT scan
compared with base,≥50% pneumonia obsorbed
Full Information
NCT ID
NCT05798195
First Posted
April 2, 2023
Last Updated
April 2, 2023
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05798195
Brief Title
Traditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital
4. Oversight
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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
controlled group
Arm Type
Active Comparator
Arm Description
conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc.
Arm Title
dexamethasone group
Arm Type
Experimental
Arm Description
dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine.
Arm Title
Chinese medicine group
Arm Type
Experimental
Arm Description
Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.
Intervention Type
Other
Intervention Name(s)
conventional western medicine treatment
Intervention Description
conventional western medicine treatment only
Intervention Type
Drug
Intervention Name(s)
Dexamethasone oral tablet
Intervention Description
treat with Dexamethasone for 2 weeks
Intervention Type
Other
Intervention Name(s)
Traditional Chinese medicine decoction
Intervention Description
treat with strengthening spleen and tonifying lung decoction for 2 weeks
Primary Outcome Measure Information:
Title
Lung CT scan
Description
compared with base,≥90% pneumonia obsorbed
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Lung CT scan
Description
compared with base,≥50% pneumonia obsorbed
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanmu Xie, Doctor
Phone
86-10-84206246
Email
xiewanmu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenguo Zhai, Dcotor
Organizational Affiliation
Department of Respiratory and Critical Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanmu Xie, Doctor
Phone
86-10-84206246
Email
xiewanmu@126.com
12. IPD Sharing Statement
Learn more about this trial
Traditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia
We'll reach out to this number within 24 hrs