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Tests treatment safety and results for Common Cold
Official title A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold
ClinicalTrials.gov ID: NCT06697886
What this study is testing
What is Antiwei Granules?
Antiwei Granules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for common cold.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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;
You likely can't join if
- Complicated with influenza, pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute pharyngeal conjunctivitis, acute viral or herpetic...
- 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...
- Primary ciliary dyskinesia syndrome, other acute onset nasal diseases (such as allergic rhinitis, chronic rhinitis, acute and chronic sinusitis...
- 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 \ 80%;
- Aspartate aminotransferase and/or alanine aminotransferase ≥ 1.5 × ULN, or serum creatinine ≥ ULN, judged by the investigator to be clinically...
See the full eligibility criteria
- 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.
- 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...
- 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 \ 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changsha, China
- Chengdu, China
- Haerbin, China
- Huizhou, China
- Kaifeng, China
- Luoyang, China
- Luzhou, China
- Nanchang, China
- Panjin, China
- Quzhou, China
- Sanmenxia, China
- Shanghai, China
- Shangqiu, China
- Shenyang, China
- Shijiazhuang, China
- Tianjin, China
- Tongzhou, China
- Xi'an, China
- Xingtai, China
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changsha, China; Chengdu, China; Haerbin, China; Huizhou, China; Kaifeng, China and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.