RecruitingPhase 3

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

China480 participantsStarted 2023-11-16

Plain-language summary

To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)

Who can participate

Age range18 Years – 65 Years

SexALL

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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;

What they're measuring

cure rate after 3 days of treatment

Timeframe: 3 days

Trial details

NCT IDNCT06697886

SponsorTasly Pharmaceutical Group Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-25

Contact for this trial

Rui Liu

022-86343726 liurui2@tasly.com

View on ClinicalTrials.gov More Common Cold trials