ITMCTR2000004094尚未招募2 期
A randomized, double-blind, parallel controlled, Phase II multicenter clinical trial of Maxing Zhixiao Granule in the treatment of bronchial asthma(heat asthma)
China-Japan Friendship Hospital0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 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 study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(1) Met the diagnostic criteria of Western medicine for bronchial asthma;
- •(2) In accordance with the diagnostic criteria of TCM asthma (Heat Asthma Syndrome);
- •(3) Chronic persistent patients with asthma control test (ACT) questionnaire score < 20;
- •(4) The severity of the disease was mild persistent and moderate persistent;
- •(5) The patients who did not use anti asthmatic drugs 2 weeks before the screening or those who had been treated with ICs or ICs + Laba for 4 weeks or more before enrollment, and the drug type and dose remained unchanged;
- •(6) Aged from 18 to 65 years old;
- •(7) Sign informed consent.
排除标准
- •(1) Refractory asthma, critical asthma, occupational asthma, seasonal asthma, atypical asthma or upper and lower respiratory tract infection, pneumonia, pulmonary tuberculosis, pulmonary interstitial fibrosis, thoracic deformity, chronic obstructive pulmonary disease, bronchiectasis, cystic pulmonary fibrosis, allergic bronchiolitis, allergic granulomatous vasculitis and other special types, infectious and restrictive Pulmonary diseases and other air flow obstructive pulmonary diseases;
- •(2) Patients with severe primary diseases of heart, brain, liver, kidney and hematopoiesis and mental illness;
- •(3) Patients with primary immunodeficiency disease and acquired immunodeficiency syndrome;
- •(4) People with allergic constitution and allergic to the drug ingredients in the test drug;
- •(5) Glutamic transaminase (ALT) and aspartate aminotransferase (AST) were 1.5 times higher than the upper limit of normal value, and serum creatinine (CR) was higher than the upper limit of normal value;
- •(6) Pregnant, lactating and pregnant women;
- •(7) Participate in other clinical studies within one month before screening;
- •(8) Those who are considered unsuitable to participate in this clinical trial.
研究者
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