Long COVID
Conditions
Interventions
Control group:Placebo and Traditional Chinese Medicine
Sponsors
China-Japanese Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years;2.Documented history of COVID-19 infection confirmed by pathogen or clinical diagnosis at least 90 days before screening (PCR positive or antibody positive);3.Presence of at least one core long COVID symptom, including fatigue, post-exertional malaise, palpitations, dyspnea, cough, sleep disturbance, brain fog, or cognitive impairment;4.Willingness to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breastfeeding women;2.History of upper respiratory tract infection within 30 days before screening;3.Use of SARS-CoV-2–specific treatments (such as monoclonal antibodies or antiviral drugs) within 30 days after enrollment;4.Planned vaccination against SARS-CoV-2 or other vaccines within 30 days prior to enrollment;5.Presence of hypothyroidism, solid or hematologic malignancy, or autoimmune disease;6.Presence of severe cardiovascular or pulmonary disease, hepatic disease (ALT/AST > 5× upper limit of normal [ULN]), renal disease, cerebrovascular disease, or psychiatric disorders or inability to comply with follow-up;7.Use of traditional Chinese medicine (TCM) within the past 90 days, long-term use of anxiolytic/antidepressant or other psychotropic drugs, or current use of drugs that may interact with the study medication;8.Recent or ongoing treatment with acupuncture, rehabilitation therapy, or participation in another clinical trial;9.History of severe allergy or intolerance to herbal formulas used in the study;10.Inability or unwillingness to provide informed consent or comply with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Core Symptom Severity at Day 30; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Core Symptom Severity at Day 60;Core Symptom Recurrence Rate at Day 90;Core Symptom Remission Rate at Day 30 and Day 60; Change in Quality of Life Scores;Change in 6-Minute Walking Distance; Change in Patient-Reported questionaires;Change in Anxiety and Depression Scores;Change in Traditional Chinese Medicine Parameters;Change in Body Surface Temperature;Change in Immunological Biomarkers;Adverse events and Safety Assessments; | — |
Countries
China
Contacts
Public ContactBin Cao
China-Japanese Friendship Hospital
Outcome results
None listed