Traditional Chinese Medicine or Low-dose Dexamethasone in COVID-19 Pneumonia
NCT ID: NCT05798195
Last Updated: 2023-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
420 participants
INTERVENTIONAL
2023-01-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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controlled group
conventional western medicine treatment including oxygen therapy, antibiotics, nebulization therapy, etc.
conventional western medicine treatment
conventional western medicine treatment only
dexamethasone group
dexamethasone 1.5mg/day for one week and 0.75mg/day for another week basing on conventional western medicine.
conventional western medicine treatment
conventional western medicine treatment only
Dexamethasone oral tablet
treat with Dexamethasone for 2 weeks
Chinese medicine group
Strengthening spleen and tonifying lung decoction for 2 weeks basing on conventional western medicine.
conventional western medicine treatment
conventional western medicine treatment only
Traditional Chinese medicine decoction
treat with strengthening spleen and tonifying lung decoction for 2 weeks
Interventions
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conventional western medicine treatment
conventional western medicine treatment only
Dexamethasone oral tablet
treat with Dexamethasone for 2 weeks
Traditional Chinese medicine decoction
treat with strengthening spleen and tonifying lung decoction for 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Zhenguo Zhai,MD,PhD
Chief physician of PCCM
Principal Investigators
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Zhenguo Zhai, Dcotor
Role: PRINCIPAL_INVESTIGATOR
Department of Respiratory and Critical Care Medicine
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-ZF-3
Identifier Type: -
Identifier Source: org_study_id
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