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
1 other identifier
interventional
480
1 country
24
Brief Summary
To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2023
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 16, 2023
CompletedFirst Submitted
Initial submission to the registry
November 18, 2024
CompletedFirst Posted
Study publicly available on registry
November 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedNovember 20, 2024
November 1, 2024
1.6 years
November 18, 2024
November 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
cure rate after 3 days of treatment
Disease recovery criteria: bad wind and cold, nasal congestion, runny nose, body pain, headache, sneezing, pharyngeal itching/sore throat symptoms were all relieved and body temperature to normal (axillary temperature \< 37.3 ° C) and was maintained for at least 24 hours. Subjects were required to be treated before the first dose, D2-Cold-related symptoms since the last evaluation were evaluated in the morning and evening of D5 and in the morning of D6, respectively.
3 days
Secondary Outcomes (8)
Time to recovery
3 days
Remission rate after 3 days of treatment
3 days
Single symptom disappearance rate after 3 days of medication
3+1 days
Efficacy of TCM syndrome after 3 days of medication
3 days
Changes in single symptom level after 3 days of medication
3 days
- +3 more secondary outcomes
Study Arms (2)
Antaiwei granules
EXPERIMENTALAntaiwei granules placebo
PLACEBO COMPARATORInterventions
During the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily.
During the 3-day treatment period, participants will receive 9 sacks of Antiwei granules. Oral administration, 1 sack (6g) per time, 3 times daily.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2024
First Posted
November 20, 2024
Study Start
November 16, 2023
Primary Completion
June 25, 2025
Study Completion
July 1, 2025
Last Updated
November 20, 2024
Record last verified: 2024-11