Evaluating Antiwei Granules for treating the common cold

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy and safety of Antiwei granules in treating the common cold, specifically focusing on patients diagnosed with wind-cold syndrome. Participants will receive either the Antiwei granules or a placebo to determine the treatment's effectiveness. The study will include male and female patients aged 18 to 65 years who have experienced symptoms for no more than 48 hours. The research will follow strict inclusion and exclusion criteria to ensure the safety and relevance of the findings.

Why it matters

Who can join: the full rules

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).

Where it's running

• Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
  Beijing, China Recruiting
• changsha Hospital Affiliated to Hunan University
  Changsha, China Recruiting
• Chengdu Pidu District Hospital of TCM
  Chengdu, China Recruiting
• Heilongiang Provincial Traditional Chinese Medicine Hospital
  Haerbin, China Recruiting
• The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
  Haerbin, China Recruiting
• Huizhou Third People's Hospital
  Huizhou, China Recruiting

Study contacts

• Study coordinator: Rui Liu
• Email: liurui2@tasly.com
• Phone: 022-86343726

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.