NCT06697886招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 24
- 主要终点
- cure rate after 3 days of treatment
研究概览
简要总结
To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Antaiwei granules
Experimental
干预措施: Antiwei Granules (Drug)
Antaiwei granules placebo
Placebo Comparator
干预措施: Antiwei Granules Placebo (Drug)
结局指标
主要结局
cure rate after 3 days of treatment
时间窗: 3 days
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.
次要结局
- 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)
- Incidence of complications(3 days)
- Proportion of subjects using emergency medication(3 days)
- The cure rate of cough and all cold symptoms after 3 days of treatment(3 days)
研究者
研究点 (24)
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