Evaluating Antiwei Granules for treating the 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

This study tests if Antiwei granules can help adults with the common cold feel better compared to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tasly Pharmaceutical Group Co., Ltd (industry)
• Locations: 24 sites (Beijing and 23 other locations)
• Trial ID: NCT06697886 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who have been diagnosed with a common cold within 48 hours of symptom onset.

Not a fit: Patients with complications from other respiratory infections or chronic nasal diseases may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from the common cold.

How similar studies have performed: While this approach is based on traditional Chinese medicine, similar studies have shown promise in treating respiratory conditions, though this specific treatment is less commonly tested.

Eligibility criteria

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 this trial is running

Beijing and 23 other locations

• 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)
• Kaifeng Hospital of Traditional Chinese Medicine — Kaifeng, China (RECRUITING)
• Luoyang Third People's Hospital — Luoyang, China (RECRUITING)
• The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University — Luzhou, China (RECRUITING)
• The Affiliated Hospital of Jiangxi Uniwersity of TCM — Nanchang, China (RECRUITING)
• Panjin Liaoyou Baoshihua Hospital — Panjin, China (RECRUITING)
• Quzhou People's Hospital — Quzhou, China (RECRUITING)
• Sanmenxia Central Hospital — Sanmenxia, China (RECRUITING)
• Longhua Hospital, Shanghai University of Traditional Chinese Medicine, — Shanghai, China (RECRUITING)
• Shangqiu First People's Hospital — Shangqiu, China (RECRUITING)
• The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medcine — Shenyang, China (RECRUITING)
• Hebei Provincial Hospital of Traditional Chinese Medicine — Shijiazhuang, China (RECRUITING)
• The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine — Tianjin, China (RECRUITING)
• Tonghua Central Hospital — Tongzhou, China (RECRUITING)
• The Second Affiliated Hospital of Shaanxi University of Chinese Medicine — Xi'an, China (RECRUITING)
• Xidian Group Hospital — Xi'an, China (RECRUITING)
• The Second Affiliated Hospital of Xingtai Higher Medical College — Xingtai, China (RECRUITING)
• Yangquan Coal Industry(Group) General Hospital — Yangquan, China (RECRUITING)
• Henan Provincial People's Hospital — Zhengzhou, China (RECRUITING)

Study contacts

• Study coordinator: Rui Liu

Conditions: Common Cold