A Study of the Efficacy and Safety of Antiwei Granules in... | NCT06697886

Status Module

Label	Type	Description	Intervention Names
Antaiwei granules	Experimental		Drug: Antiwei Granules
Antaiwei granules placebo	Placebo Comparator		Drug: Antiwei Granules Placebo

Name	Type	Description	Arm Group Labels	Other Names
Antiwei Granules	Drug	During the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily.	Antaiwei granules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 days

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;
At enrollment, 37.3 ° C ≤axillary temperature < 38.5 ° C;
Informed consent was obtained voluntarily.

Exclusion Criteria:

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;
White blood cell count >12.0×10^9/L or <3.0×10^9/L , And/or neutrophil percentage >80%;
Aspartate aminotransferase and/or alanine aminotransferase ≥ 1.5 × ULN, or serum creatinine ≥ ULN, judged by the investigator to be clinically significant；
Combined with other serious primary diseases of the heart, brain, lung, liver, kidney or blood system, such as unstable control/serious complications of diabetes, viral hepatitis, hemophilia, or mental disorders;
Patients who had been treated with Chinese and western drugs for the relief of common cold and its symptoms after the onset of the current illness, including but not limited to antibiotics, antiviral, antihistamine, steroids, decongestants, antipyretic and analgesic, antitussive and expectorant drugs etc;
Those who were allergic to the known composition of the investigational drug or to emergency medication, or emergency drug contraindication population;
The participants (and their partners) had planned pregnancy or were unwilling to take appropriate contraceptive measures from enrollment to 1 month after the end of the trial, or were pregnant or lactating;
Suspected or true history of alcohol or drug abuse;
Participants who had participated in another clinical trial within 1 month before enrollment;
Persons deemed unsuitable for clinical trial by the investigator (e.g., athletes or persons not eligible for enrollment for other reasons).

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases