ITMCTR2024000075尚未招募Unknown
Modern in-depth research and development of large varieties of Chinese patent medicines for respiratory diseases-a study on the clinical relevance of Traditional Chinese Medicine compounds
China-Japan Friendship Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40 至 80（—）
- 性别
- All
入选标准
- •(1) Meet the diagnostic criteria of AECOPD in Western medicine;
- •(2) AECOPD severity grade I-II;
- •(3) Conforming to the TCM standard for syndrome differentiation of phlegm-heat obstructing lung;
- •(4) Age 40-80 years old, gender is not limited;
- •(5) Voluntarily participate in this clinical trial, give informed consent and sign informed consent.
排除标准
- •(1) Combined with other serious lung diseases, such as bronchial asthma, active pulmonary tuberculosis, pulmonary embolism, pulmonary abscess, lung cancer, interstitial lung disease, pneumothorax or other air limitation diseases with known etiology and characteristic pathological manifestations;
- •(2) Diseases associated with exertional dyspnea, such as aortic insufficiency, heart failure, pulmonary hypertension, severe anemia, myocardial infarction, etc.;
- •(3) Serious diseases with severe cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system and endocrine system, which are considered not suitable for participation in this study;
- •(4) Indications of invasive mechanical ventilation and non-invasive ventilator application;
- •(5) long-term use of systemic glucocorticoids;
- •(6) Combined use of immunosuppressants is required;
- •(7) Standardized oral antibiotics or intravenous antibiotics for more than 3 days in the week before screening;
- •(8) The use of traditional Chinese medicine preparations or chemical drugs similar to the Qingjin Huatan decoction formula or the same functional indications for more than 3 days before screening;
- •(9) ALT and AST > 1.5 times the upper limit of normal reference value or Scr > the upper limit of normal reference value;
- •(10) Pregnant and lactating women;
- •(11) having intellectual or mental disabilities;
- •(12) known allergy to the basic therapeutic drug or any excipient prescribed in the protocol;
- •(13) known to be allergic to Qingjin Huatan decoction prescription drug ingredients;
- •(14) Have participated in or are participating in other clinical trials within the last 1 month;
- •(15) The investigator considers it inappropriate to participate in this clinical trial.
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