COVID-19 infected disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1)Age (18 = and =65) years old, gender is not limited; (2)Meet the diagnosis of The Pneumonia Diagnosis and Treatment Guideline for Novel Corona-virus Infection (Trial Version 10); (3)Clinical classification is mild; (4)Traditional Chinese medicine syndrome differentiation is Yidu Shubiao Syndrome; (5)Within 72 hours from the onset of COVID-19-related symptoms to random enrollment (details are provided in Supplemental Appendix 1); (6)At least one COVID-19-related symptom (cough, nasal congestion, sore throat, fever) score = 2 points : Cough Fatigue; Nausea; Dysgeusia Stuffy or Runny Nose; Headache; Vomit; Dysosmia Sore or Dry Throat; Fever; Diarrhea Shortness of Breath or Difficulty Breathing; Muscle or General Body Pain Chills or Shaking; (7) Volunteer to participate in this clinical trial, give informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) The clinical classification of COVID-19 is moderate, severe, and critical; (2) Combining diseases with the same clinical manifestations as COVID-19-related symptoms, such as influenza, infectious diseases with the above symptoms as prodromal symptoms, pneumonia, suppurative tonsillitis, acute tracheo-bronchitis, tuberculosis, and primary ciliary movement Dysfunction syndrome, other acute nasal diseases (such as allergic rhinitis, acute and chronic rhinitis, acute and chronic sinusitis, etc.), nasal mucosal dysfunction after nasal surgery or nasopharynx radiotherapy; (3) Patients with serious cardiovascular and cerebrovascular diseases (including hypertension with uncontrolled and stable blood pressure), chronic lung diseases, diabetes, chronic liver, kidney diseases, tumors and other basic diseases, as well as maintenance dialysis patients; (4) Immunodeficiency (such as AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs lead to a state of hypoimmune function); (5) Obesity (body mass index = 30kg/m2); (6) Severe smoking (smoking severity index = 4 points); (7) Liver function ALT and AST exceed 2 times the upper limit of the normal reference value or Scr exceeds the upper limit of the normal reference value; (8) 4 hours before enrollment, used anti-new coronary pneumonia virus infection, cold medicine, antiviral medicine, antibiotics, antipyretic analgesics and other traditional Chinese medicines and chemical medicines that affect the evaluation of curative effect; (9) Combined with serious primary diseases such as hematopoietic system and mental illness; (10) Pregnancy or women who plan to become pregnant or breastfeeding during the study period; (11) History of allergy to the test drug ingredients; (12) History of long-term alcoholism and drug abuse; (13) Participated in other interventional drug clinical trials within the past month; (14) The investigator thinks patients who is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time from initiation of treatment to patients’ COVID-19 related-symptoms sustained clinical recovery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieved sustained recovery of symptoms each day during the study;;Time from subject's initiation of treatment to sustained relief of COVID-19 symptoms;Other effectiveness evaluation indicators; | — |
Countries
China
Contacts
Shenzhen Third People's Hospital