2.3. Intervention and efficacy evaluation

Random numbers were generated by SAS statistical analysis software (version 9.2), and patients were grouped using a block random method. Data analysis was completed independently by professional statisticians. All study participants received the western medicine treatment plan recommended by the novel coronavirus's pneumonia diagnosis and treatment program (Seventh Edition) jointly issued by the State Health Commission and the State Administration of Traditional Chinese Medicine. The specific recommendations were as follows: 1) Antiviral treatment with oral oseltamivir (75 mg per tablet) one tablet, once a day; Arbidol (100 mg per tablet) taken orally, two tablets three times a day; Ribavirin (100 mg per tablet) taken orally, one and a half tablets three times a day; 2) Antimicrobial therapy: strengthen bacteriological monitoring and use antibiotics when there is evidence of a secondary bacterial infection using oral penicillins, cephalosporins, ofloxacin, and macrolide etc.

In addition to western medicine, participants in Huoxiang + Lianhua group were treated with Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules. Participants took one bag of Huoxiang Zhengqi dropping pills twice a day and one bag of Lianhua Qingwen granules three times a day. Subjects in Lianhua only group were treated with Lianhua Qingwen granules and western medicine, taking one bag of Lianhua Qingwen three times a day. Finally, participants in the western medicine group were only treated with western medicine and were not treated with TCM.

All subjects underwent symptom assessment and body temperature and vital signs monitoring (blood pressure, heart and respiration rates). Medication compliance was recorded, as well as adverse events, before and after 14 days of treatment. The main outcome measures were clinical symptom improvement and disappearance rates after 14 days of treatment, and the secondary outcome measure was the proportion of patients who progressed to severe status despite the same duration of treatment.