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

Last updated: November 18, 2024
Sponsor: Tasly Pharmaceutical Group Co., Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Acute Rhinitis

Common Cold

Treatment

Antiwei Granules Placebo

Antiwei Granules

Clinical Study ID

NCT06697886
TSL-TCM-ATWKL-Ⅲ
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Complicated with influenza, pneumonia, suppurative tonsillitis, acutetracheobronchitis, acute pharyngeal conjunctivitis, acute viral or herpeticpharyngitis, acute viral or herpetic laryngitis;

  2. Patients who had been infected with 2019-ncov in the past and still had symptomssuch as cough and fatigue for nearly 3 months after the antigen turned negative;

  3. Primary ciliary dyskinesia syndrome, other acute onset nasal diseases (such asallergic rhinitis, chronic rhinitis, acute and chronic sinusitis, etc.), previousnasal surgery or radiotherapy of the nasopharynx with nasal mucosal dysfunction;

  4. Patients with chronic respiratory diseases (such as chronic obstructive pulmonarydisease, 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 serumcreatinine ≥ 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 ofcommon cold and its symptoms after the onset of the current illness, including butnot 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 toemergency medication, or emergency drug contraindication population;

  10. The participants (and their partners) had planned pregnancy or were unwilling totake appropriate contraceptive measures from enrollment to 1 month after the end ofthe 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 beforeenrollment;

  13. Persons deemed unsuitable for clinical trial by the investigator (e.g., athletes orpersons not eligible for enrollment for other reasons).

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: Antiwei Granules Placebo
Phase: 3
Study Start date:
November 16, 2023
Estimated Completion Date:
July 01, 2025

Connect with a study center

  • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • changsha Hospital Affiliated to Hunan University

    Changsha,
    China

    Active - Recruiting

  • Chengdu Pidu District Hospital of TCM

    Chengdu,
    China

    Active - Recruiting

  • Heilongiang Provincial Traditional Chinese Medicine Hospital

    Haerbin,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

    Haerbin,
    China

    Active - Recruiting

  • Huizhou Third People's Hospital

    Huizhou,
    China

    Active - Recruiting

  • Kaifeng Hospital of Traditional Chinese Medicine

    Kaifeng,
    China

    Active - Recruiting

  • Luoyang Third People's Hospital

    Luoyang,
    China

    Active - Recruiting

  • The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University

    Luzhou,
    China

    Active - Recruiting

  • The Affiliated Hospital of Jiangxi Uniwersity of TCM

    Nanchang,
    China

    Active - Recruiting

  • Panjin Liaoyou Baoshihua Hospital

    Panjin,
    China

    Active - Recruiting

  • Quzhou People's Hospital

    Quzhou,
    China

    Active - Recruiting

  • Sanmenxia Central Hospital

    Sanmenxia,
    China

    Active - Recruiting

  • Longhua Hospital, Shanghai University of Traditional Chinese Medicine,

    Shanghai,
    China

    Active - Recruiting

  • Shangqiu First People's Hospital

    Shangqiu,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medcine

    Shenyang,
    China

    Active - Recruiting

  • Hebei Provincial Hospital of Traditional Chinese Medicine

    Shijiazhuang,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin,
    China

    Active - Recruiting

  • Tonghua Central Hospital

    Tongzhou,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    Xian,
    China

    Active - Recruiting

  • Xidian Group Hospital

    Xian,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xingtai Higher Medical College

    Xingtai,
    China

    Active - Recruiting

  • Yangquan Coal Industry(Group) General Hospital

    Yangquan,
    China

    Active - Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou,
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.