A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold
ConditionCommon Cold
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTasly Pharmaceutical Group Co., Ltd
About this trial
To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
It met the diagnostic criteria of common cold in western medicine;
In accordance with the TCM syndrome differentiation standard of wind-cold syndrome;
Male and female patients aged 18 to 65 years;
The disease duration at enrollment was ≤48 h;
Disqualifiers
Complicated with influenza, pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute pharyngeal conjunctivitis, acute viral or herpetic pharyngitis, acute viral or herpetic laryngitis;
Patients who had been infected with 2019-ncov in the past and still had symptoms such as cough and fatigue for nearly 3 months after the antigen turned negative;
Primary ciliary dyskinesia syndrome, other acute onset nasal diseases (such as allergic rhinitis, chronic rhinitis, acute and chronic sinusitis, etc.), previous nasal surgery or radiotherapy of the nasopharynx with nasal mucosal dysfunction；
Patients with chronic respiratory diseases (such as chronic obstructive pulmonary disease, interstitial lung disease, etc.), asthma, and tuberculosis;
Trial design
Design model
Parallel
Treatments tested in this trial
Antiwei Granules
DrugDuring the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily.
Antiwei Granules Placebo
DrugDuring the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily.
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: Antaiwei granulesExperimental treatment 1 intervention
Group B: Antaiwei granules placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
cure rate after 3 days of treatment
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.
Time frame
3 daysSecondary outcomes
1
Time to recovery
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
Time frame
3 days2
Remission rate after 3 days of treatment
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.
Time frame
3 days3
Single symptom disappearance rate after 3 days of medication
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.
Time frame
3+1 days4
Efficacy of TCM syndrome after 3 days of medication
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.
Time frame
3 daysSponsors and contacts
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Source ClinicalTrials.gov