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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 II Clinical Trial
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2024-11-20
480
Participants Needed
24
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Antiwei granules for treating the common cold, specifically the wind-cold syndrome. This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial sponsored by Tasly Pharmaceutical Group Co., Ltd. It aims to assess how well Antiwei granules work and how safe they are in adults aged 18 to 65 with recent onset of common cold symptoms. Participants will be randomly assigned to receive either Antiwei granules or a matching placebo. The treatment involves taking one sachet of granules (6 grams) orally three times a day, for three days. Both groups follow the same dosing schedule, taking nine sachets total. The study compares outcomes between the Antiwei granule group and the placebo group over this short treatment period. Throughout the trial, participants will be closely monitored with assessments focusing on the cure rate after three days of treatment. Researchers will also track symptom recovery time, remission rate, disappearance of individual symptoms, traditional Chinese medicine syndrome efficacy, changes in symptom severity, occurrence of complications, emergency medication use, and overall cure of cough and cold symptoms. The total participation time includes the three-day treatment and monitoring period to evaluate treatment effects and safety.
CONDITIONS
Brief 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 meets common cold criteria in western medicine
- Meets traditional Chinese medicine wind-cold syndrome criteria
- Male or female aged 18 to 65 years
- Disease started within 48 hours before enrollment
- Axillary temperature between 37.3 �b0C and less than 38.5 �b0C at enrollment
- Provided informed consent voluntarily
You will not qualify if you...
- Having influenza, pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute pharyngeal conjunctivitis, acute viral or herpetic pharyngitis, or acute viral or herpetic 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 previous nasal surgery/radiotherapy causing nasal dysfunction
- Chronic respiratory diseases such as COPD, interstitial lung disease, asthma, or tuberculosis
- White blood cell count above 12.0 x10^9/L or below 3.0 x10^9/L, or neutrophil percentage above 80%
- Elevated liver enzymes or serum creatinine judged clinically significant
- Serious primary diseases of heart, brain, lung, liver, kidney, or blood system including unstable diabetes, viral hepatitis, hemophilia, or mental disorders
- Treated with antibiotics, antivirals, antihistamines, steroids, decongestants, antipyretics, analgesics, antitussives, or expectorants after current illness onset
- Allergy to investigational drug components or emergency medications
- Planned pregnancy or unwillingness to use contraception during and one month after trial, or pregnancy or lactation
- History of alcohol or drug abuse
- Participated in another clinical trial within 1 month before enrollment
- Considered unsuitable for trial participation by investigator, including athletes or other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive Antiwei granules or placebo orally, 3 times daily for 3 days to treat common cold symptoms.
1 baseline visit and 1 follow-up visit
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
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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