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

Tasly Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Common Cold

Treatments: Drug: Antiwei Granules; Drug: Antiwei Granules Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06697886

TSL-TCM-ATWKL-Ⅲ

Details and patient eligibility

About

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

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. It met the diagnostic criteria of common cold in western medicine;
2. In accordance with the TCM syndrome differentiation standard of wind-cold syndrome;
3. Male and female patients aged 18 to 65 years;
4. The disease duration at enrollment was ≤48 h;
5. At enrollment, 37.3 ° C ≤axillary temperature < 38.5 ° C;
6. Informed consent was obtained voluntarily.

Exclusion criteria

1. Complicated with influenza, pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute pharyngeal conjunctivitis, acute viral or herpetic pharyngitis, acute viral or herpetic laryngitis;
2. 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;
3. 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；
4. Patients with chronic respiratory diseases (such as chronic obstructive pulmonary disease, interstitial lung disease, etc.), asthma, and tuberculosis;
5. White blood cell count >12.0×10^9/L or <3.0×10^9/L , And/or neutrophil percentage >80%;
6. Aspartate aminotransferase and/or alanine aminotransferase ≥ 1.5 × ULN, or serum creatinine ≥ ULN, judged by the investigator to be clinically significant；
7. 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;
8. 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;
9. Those who were allergic to the known composition of the investigational drug or to emergency medication, or emergency drug contraindication population;
10. 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;
11. Suspected or true history of alcohol or drug abuse;
12. Participants who had participated in another clinical trial within 1 month before enrollment;
13. Persons deemed unsuitable for clinical trial by the investigator (e.g., athletes or persons not eligible for enrollment for other reasons).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

480 participants in 2 patient groups, including a placebo group

Antaiwei granules

Experimental group

Treatment:

Drug: Antiwei Granules

Antaiwei granules placebo

Placebo Comparator group

Treatment:

Drug: Antiwei Granules Placebo