ITMCTR2100004508招募中1 期
Confirmatory clinical trial on the efficacy and safety of Zhizhike Granule in the treatment of acute tracheal bronchitis (wind-heat lung disease)
Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •1. Patients meeting the diagnostic criteria of acute tracheobronchitis;
- •2. Patients who meet the diagnostic criteria of wind heat invading lung syndrome of traditional Chinese medicine;
- •3. Patients with vas >= 60mm;
- •4. Patients aged between 18 and 65, male and female;
- •5. Patients whose course of disease is within 7 days;
- •6. Patients who voluntarily received the drug and signed the informed consent.
排除标准
- •The patients with any of the following conditions could not be included in this trial:
- •1. Patients with chronic bronchitis, chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer, tuberculosis, pneumonia, lung abscess and chest X-ray showing pulmonary inflammatory lesions and other respiratory diseases;
- •2. Patients with serious primary diseases of cardiovascular, cerebrovascular, pulmonary, renal and hematopoietic systems; diabetic patients; patients with abnormal ECG and clinical significance;
- •3. Patients who smoke;
- •4. Patients using ACEI drugs;
- •5. Patients with body temperature >= 38.5 degrees C;
- •6. Patients with liver function test value (ALT, AST) exceeding 1.5 times of the upper limit of normal value; SCR higher than the upper limit of normal reference value, or / and BUN higher than 1.5 times of the upper limit of normal value, or / and UA higher than 1.5 times of the upper limit of normal value; WBC less than 3.0 x 10^9 / L or greater than 10.0 x 10^9 / L, and / or neutrophil percentage > 80%; fasting blood glucose greater than or equal to 6.9 mmol / L; and;
- •7. Patients who have used other drugs to treat the disease after onset (including antibiotics, expectorants, antitussive drugs, systemic or inhaled sex hormones, inhaled bronchodilators, Xinliang jiebiao, Qingre Jiedu and other related traditional Chinese Medicine);
- •8. Pregnant, lactating women and subjects with pregnancy plans in the last 3 months;
- •9. Subjects with allergic constitution or allergic to known components of the drug;
- •10. Patients with serious diseases (such as tumor, etc.) and psychosis that affect their survival;
- •11. Patients who have participated in clinical trials of other drugs within one month and are currently participating in clinical trials of other drugs;
- •12. The researchers believe that there are patients who are not suitable for inclusion.
研究者
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