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

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05798195

Enrollment

420

Registered

2023-04-04

Start date

2023-01-01

Completion date

2024-12-31

Last updated

2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia

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.

Interventions

OTHERconventional western medicine treatment

conventional western medicine treatment only

DRUGDexamethasone oral tablet

treat with Dexamethasone for 2 weeks

OTHERTraditional Chinese medicine decoction

treat with strengthening spleen and tonifying lung decoction for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactWanmu Xie, Doctor

xiewanmu@126.com86-10-84206246

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026