A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold

Disease recovery criteria: bad wind and cold, nasal congestion, runny nose, body pain, headache, sneezing, pharyngeal itching/sore throat symptoms were all relieved and body temperature to normal (axillary temperature < 37.3 ° C) and was maintained for at least 24 hours.

Subjects were required to be treated before the first dose, D2-Cold-related symptoms since the last evaluation were evaluated in the morning and evening of D5 and in the morning of D6, respectively.

Disease recovery criteria: bad wind and cold, nasal congestion, runny nose, body pain, headache, sneezing, pharyngeal itching/sore throat symptoms were all relieved and body temperature to normal (axillary temperature < 37.3 ° C) and was maintained for at least 24 hours.

Subjects were asked to evaluate their cold-related symptoms since the last evaluation before the first dose, in the morning and evening of D2-D5, and in the morning of D6. Visit 2 occurred on the morning of D6 after the assessment was completed.

If the participant in visit 2 did not reach the recovery criteria according to the investigator's judgment, the diary card was reissued and the cold-related symptoms since the last evaluation were evaluated in the evening of D6, the morning and evening of D7, and the morning of D8

Disease remission criteria: bad wind and cold, nasal congestion, runny nose, body pain, headache, sneezing, pharyngeal itching/sore throat were all asymptomatic or mild, and body temperature to normal (axillary temperature < 37.3 ° C) and was maintained for at least 24 hours.

The ratio of subjects who achieved the remission standard after 3 days of medication was calculated, and whether the remission standard was reached was determined according to the morning and evening evaluation of D2-D5.

Single symptoms included bad wind and cold, nasal congestion, runny nose, body pain, headache, sneezing, pharyngeal itching/sore throat .

Single symptom disappearance was defined as the disappearance of each single symptom (axillary temperature < 37.3℃) and maintained for at least 24 hours.

After 3 days of treatment, the proportion of subjects who were cured/better/effective in each group was calculated.Clinical recovery: clinical symptoms and signs basically disappeared or completely disappeared, and the syndrome score decreased by ≥95% compared with the baseline. Marked effect: the clinical symptoms and signs were significantly improved, and the syndrome score was reduced by ≥70% compared with the baseline. Effective: the clinical symptoms and signs were improved, and the syndrome score decreased by ≥30% compared with the baseline; No effect: the clinical symptoms and signs did not change, or even had a trend of aggravation, and the syndrome score decreased less than 30% compared with the baseline.

The change of each symptom score from baseline to 3 days after treatment was calculated.

Single symptom: bad wind and cold, nasal congestion, runny nose, body pain, headache, fever, sneezing, pharyngeal itching/sore throat, cough, fatigue.

The proportion of subjects with complications (including acute sinusitis, otitis media, tracheobronchitis, pneumonia, etc.) during the period from the first administration of the trial drug to the completion of the trial was calculated.

If the subject's body temperature (axillary temperature) exceeds 39 ° C during the trial, If the body temperature reaches 38.5℃ or above for 4 hours, or if the patient cannot tolerate it, temporary acetaminophen tablets can be taken according to the doctor's advice.

Cough and all cold symptoms recovery criteria: cough, bad wind and cold, nasal congestion, runny nose, body pain, headache, sneezing, pharyngeal itching/sore throat symptoms were all relieved and body temperature to normal (axillary temperature < 37.3 ° C) and was maintained for at least 24 hours.