ITMCTR2100004437招募中3 期
Efficacy and Safety of Tanreqing Oral Liquid in Treatment of Acute Bronchitis (Phlegm-Heat Obstructing Lungs Syndrome): a multicenter, randomized, double-blind, placebo-controlled trial
West China Hospital, Sichuan University0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 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
- 性别
- All
入选标准
- •1. Diagnosis of acute trachea-bronchitis;
- •2. Phlegm-heat obstructing lungs syndrome in traditional Chinese medicine 'Zheng';
- •3. Total cough symptom score >=4 points;
- •4. Expectoration in traditional Chinese medicine symptom score >=6 points;
- •5. Bronchitis severity score>=6 points;
- •6. Disease course within 72 hours;
- •7. Aged 18 to 65 years old;
- •8. Voluntarily provide written and informed consent.
排除标准
- •1. Patients with respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis, asthma, lung cancer, tuberculosis, pneumonia, lung abscess and chest X-ray showing lung inflammation lesions;
- •2. Patient with severe underlying cardiac, cerebral, hematological, hepatic or renal disorders or other diseases significantly affecting the survival and prognosis, such as cancer;
- •3. Current smokers or recent ex-smokers quitting smoking less than 1 month ago;
- •4. Use of an angiotensin-converting-enzyme inhibitor in the last 1 month
- •5. Patients with body temperature>=38.5 degree C;
- •6. ALT or AST>1.5 ULN, urine protein>+, serum creatine abnormality, white blood cell count<3x10^9/L or >10x10^9/L, and or neutrophil granulocyte>80%, or those who need antibiotic therapy;
- •7. Those who have used other medicines after disease onset including antibiotics, expectorants, antitussives, systemic or inhaled corticosteroids, inhaled bronchodilators, Chinese medicines of relieving exterior syndrome with pungent-cool drugs, clearing away heat and detoxification and other related Chinese medicines;
- •8. Pregnant or lactating women and those who have pregnancy plans in the last 3 months;
- •9. Allergic constitution or known to be allergic to any ingredients in tested drug;
- •10. Mental patients or legal disability;
- •11. Patients who have participated or are currently participating in another clinical trial in the last one month;
- •12. Patients who are inappropriate for participation judged by researchers.
研究者
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