Covid-19
Conditions
Interventions
experimental group:Sanhanhuashi granules
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-70 years (inclusive), regardless of gender; 2. Diagnosis of COVID-19 by SARS-CoV-2 nucleic acid test/or antigen test; 3.The subjects were classified as mild/moderate type COVID-19; 4. First onset of symptoms <= 72 hours from first dose of trial drug; 5. Three or more of the following symptoms: fever, stuffy or runny nose, sore throat, cough, shortness of breath or difficulty breathing, muscle or body aches, headache, malaise, nausea, vomiting, diarrhea; 6. Signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Investigators to be likely to progress to severe or critical COVID-19 before randomization; 2. Meets severe/critical early warning indicators; 3. Aged > 65 years and not vaccinated against the Covid-19 vaccine; 4. Chronic lung disease (e.g., chronic obstructive pulmonary disease, moderate/severe asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension) and maintenance dialysis; 5. Compromised immune system (e.g., AIDS , long-term use of corticosteroids or other immunosuppressive drugs resulting in a hypoimmune state); 6. Obese (BMI >= 30 kg/m2); 7. Heavy smokers; 8. Pregnant patients, pregnant patients and breastfeeding patients; 9. Male subjects whose wives or partners are planning to become pregnant during the study period; 10. Have used the same type of proprietary Chinese medicine for more than 2 days before enrollment; 11. Treatment with antivirals against SARS-CoV-2 or SARS-CoV-2 monoclonal antibody prior to randomization; 12. Have received neutralizing antibodies or convalescent plasma therapy due to COVID-19; 13. Those who used drugs prohibited in the Paxlovid instructions before enrollment; 14. Has hypersensitivity or other contraindication to any of the components of the study interventions; 15. Those with a white blood cell count exceeding 20% of the upper limit of normal in routine blood work, or those with large amounts of pus sputum suspected of bacterial infection; 16.Previous administration with any investigational drug within 30 days before the study drug administration; 17.Patients who are considered unsuitable for clinical trials by the researcher.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Time to resolution of individual symptoms and rate of resolution of individual symptoms;AUC of COVID-19-related symptom score-time;Time to onset of fever reduction and time for normalization of body temperature;Evaluation of rate to negative conversion of SARS-CoV-2 by RT-PCR ;Evaluation of time to negative conversion of SARS-CoV-2 by antigen detection ;Proportion of cases progressing to severe/critical cases;Mortality rate during the study;The number and frequency of emergency drugs used;Incidence of adverse events/adverse reactions; | — |
Primary
| Measure | Time frame |
|---|---|
| Time from COVID-19-related symptoms to sustained clinical recovery; | — |
Countries
China
Contacts
Public ContactCao Bin
China-Japan Friendship Hospital
Outcome results
None listed