Clinical trial NCT06697886: A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Common Cold
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: cure rate after 3 days of treatment
timeFrame: 3 days
Secondary outcomes:
measure: Time to recovery
timeFrame: 3 days
measure: Remission rate after 3 days of treatment
timeFrame: 3 days
measure: Single symptom disappearance rate after 3 days of medication
timeFrame: 3+1 days
measure: Efficacy of TCM syndrome after 3 days of medication
timeFrame: 3 days
measure: Changes in single symptom level after 3 days of medication
timeFrame: 3 days
measure: Incidence of complications
timeFrame: 3 days
measure: Proportion of subjects using emergency medication
timeFrame: 3 days
measure: The cure rate of cough and all cold symptoms after 3 days of treatment
timeFrame: 3 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
city: Changsha
country: China
facility: changsha Hospital Affiliated to Hunan University
city: Chengdu
country: China
facility: Chengdu Pidu District Hospital of TCM
city: Haerbin
country: China
facility: Heilongiang Provincial Traditional Chinese Medicine Hospital
city: Haerbin
country: China
facility: The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
city: Huizhou
country: China
facility: Huizhou Third People's Hospital
city: Kaifeng
country: China
facility: Kaifeng Hospital of Traditional Chinese Medicine
city: Luoyang
country: China
facility: Luoyang Third People's Hospital
city: Luzhou
country: China
facility: The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University
city: Nanchang
country: China
facility: The Affiliated Hospital of Jiangxi Uniwersity of TCM
city: Panjin
country: China
facility: Panjin Liaoyou Baoshihua Hospital
city: Quzhou
country: China
facility: Quzhou People's Hospital
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of Traditional Chinese Medicine,
city: Shangqiu
country: China
facility: Shangqiu First People's Hospital
city: Shenyang
country: China
facility: The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medcine
city: Shijiazhuang
country: China
facility: Hebei Provincial Hospital of Traditional Chinese Medicine
city: Tianjin
country: China
facility: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
city: Tongzhou
country: China
facility: Tonghua Central Hospital
city: Xian
country: China
facility: The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
city: Xian
country: China
facility: Xidian Group Hospital
city: Xingtai
country: China
facility: The Second Affiliated Hospital of Xingtai Higher Medical College
city: Yangquan
country: China
facility: Yangquan Coal Industry(Group) General Hospital
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
References: