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A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2024-11-20
480
Participants Needed
24
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)
CONDITIONS
Official Title
A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of common cold by western medicine criteria
- Meets traditional Chinese medicine criteria for wind-cold syndrome
- Male or female aged 18 to 65 years
- Cold symptoms started within 48 hours before enrollment
- Axillary temperature between 37.3°C and less than 38.5°C at enrollment
- Provided voluntary informed consent
You will not qualify if you...
- Complicated with influenza, pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute pharyngeal conjunctivitis, or acute viral/herpetic pharyngitis or laryngitis
- Previous 2019-nCoV infection with ongoing symptoms like cough or fatigue for nearly 3 months after antigen negative
- Primary ciliary dyskinesia syndrome or other acute nasal diseases or prior nasal surgery/radiotherapy causing nasal mucosal dysfunction
- Chronic respiratory diseases including COPD, interstitial lung disease, asthma, or tuberculosis
- White blood cell count greater than 12.0x10^9/L or less than 3.0x10^9/L, or neutrophils over 80%
- Elevated liver enzymes (AST/ALT ≥1.5x ULN) or serum creatinine above ULN judged clinically significant
- Serious primary diseases of heart, brain, lung, liver, kidney, or blood system including uncontrolled diabetes, viral hepatitis, hemophilia, or mental disorders
- Use of any medications for common cold symptoms after current illness onset including antibiotics, antivirals, antihistamines, steroids, decongestants, antipyretics, analgesics, antitussives, or expectorants
- Allergy to investigational drug components or emergency medications
- Pregnant, lactating, planning pregnancy, or unwilling to use contraception from enrollment until one month post-trial
- History of alcohol or drug abuse
- Participation in another clinical trial within one month before enrollment
- Deemed unsuitable for clinical trial by investigator, including athletes or other ineligible persons
AI-Screening
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Trial Site Locations
Total: 24 locations
1
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, China
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2
changsha Hospital Affiliated to Hunan University
Changsha, China
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3
Chengdu Pidu District Hospital of TCM
Chengdu, China
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4
Heilongiang Provincial Traditional Chinese Medicine Hospital
Haerbin, China
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5
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Haerbin, China
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6
Huizhou Third People's Hospital
Huizhou, China
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7
Kaifeng Hospital of Traditional Chinese Medicine
Kaifeng, China
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8
Luoyang Third People's Hospital
Luoyang, China
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9
The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University
Luzhou, China
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10
The Affiliated Hospital of Jiangxi Uniwersity of TCM
Nanchang, China
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11
Panjin Liaoyou Baoshihua Hospital
Panjin, China
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12
Quzhou People's Hospital
Quzhou, China
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13
Sanmenxia Central Hospital
Sanmenxia, China
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14
Longhua Hospital, Shanghai University of Traditional Chinese Medicine,
Shanghai, China
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15
Shangqiu First People's Hospital
Shangqiu, China
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16
The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medcine
Shenyang, China
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17
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, China
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18
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, China
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19
Tonghua Central Hospital
Tongzhou, China
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20
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xi'an, China
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21
Xidian Group Hospital
Xi'an, China
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22
The Second Affiliated Hospital of Xingtai Higher Medical College
Xingtai, China
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23
Yangquan Coal Industry(Group) General Hospital
Yangquan, China
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24
Henan Provincial People's Hospital
Zhengzhou, China
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Research Team
R
Rui Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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