RecruitingPhase 3NCT06697886

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

To Evaluate the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold (Wind-cold Syndrome) in a Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Trial


Sponsor

Tasly Pharmaceutical Group Co., Ltd

Enrollment

480 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

  • 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 Criteria13

  • 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).

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Interventions

DRUGAntiwei Granules

During the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily.

DRUGAntiwei Granules Placebo

During the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily.


Locations(24)

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Beijing, China

changsha Hospital Affiliated to Hunan University

Changsha, China

Chengdu Pidu District Hospital of TCM

Chengdu, China

Heilongiang Provincial Traditional Chinese Medicine Hospital

Haerbin, China

The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Haerbin, China

Huizhou Third People's Hospital

Huizhou, China

Kaifeng Hospital of Traditional Chinese Medicine

Kaifeng, China

Luoyang Third People's Hospital

Luoyang, China

The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University

Luzhou, China

The Affiliated Hospital of Jiangxi Uniwersity of TCM

Nanchang, China

Panjin Liaoyou Baoshihua Hospital

Panjin, China

Quzhou People's Hospital

Quzhou, China

Sanmenxia Central Hospital

Sanmenxia, China

Longhua Hospital, Shanghai University of Traditional Chinese Medicine,

Shanghai, China

Shangqiu First People's Hospital

Shangqiu, China

The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medcine

Shenyang, China

Hebei Provincial Hospital of Traditional Chinese Medicine

Shijiazhuang, China

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Tonghua Central Hospital

Tongzhou, China

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xi'an, China

Xidian Group Hospital

Xi'an, China

The Second Affiliated Hospital of Xingtai Higher Medical College

Xingtai, China

Yangquan Coal Industry(Group) General Hospital

Yangquan, China

Henan Provincial People's Hospital

Zhengzhou, China

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NCT06697886


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