ITMCTR2100004651尚未招募4 期
Efficacy and safety of huashanshen dripping pills in the treatment of stable chronic obstructive pulmonary disease: a multicenter, randomized, double-blind, placebo-controlled clinical trial
The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 4 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
- 40 至 80（—）
- 性别
- All
入选标准
- •1. Meet the diagnostic criteria of COPD.
- •2. Accord with the syndrome differentiation standard of lung spleen kidney deficiency and phlegm stasis syndrome (non heat syndrome) in the stable stage of lung distension.
- •3. 40 years old = 80 years old.
- •4. The patient was diagnosed with COPD at least 12 months before the screening visit (according to the diagnostic criteria of gold 2020 guidelines), and had entered a stable period of more than 1 month before the screening visit, and the maintenance treatment plan met the basic treatment requirements of gold 2020 guidelines.
- •5. Severity of COPD: MMRC dyspnea severity grade = 1.
- •6. There was at least one history of disease aggravation within 12 months before the screening visit, and there was a record of using inhaled short acting bronchodilator (salbutamol sulfate) as a rapid remission drug.
- •7. The subjects are willing and able to adjust the current COPD treatment according to the protocol requirements.
- •8. Voluntarily participate in the clinical trial and sign the informed consent.
排除标准
- •1. In addition to COPD, there are known respiratory diseases that may affect the efficacy of the study drug, including but not limited to asthma, a - 1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension and interstitial lung disease.
- •2. Patients need to use the following drugs: A. systemic steroids were used for the treatment of COPD exacerbation within 4 weeks before screening. b. Within 4 weeks before screening, the course of antibiotic treatment for COPD exacerbation was more than 7 days. c. Phosphodiesterase (PDE) inhibitors were used within 4 weeks before screening. d. Antibiotics were used to treat lower respiratory tract infections (e.g. pneumonia) within 4 weeks before screening.
- •3. Patients need long-term inhalation of bronchodilators containing long-acting anticholinergic drugs as basic treatment.
- •4. Patients need long-term (at least 12 hours a day) oxygen for the treatment of chronic hypoxemia.
- •5. The abnormality of chest X-ray or CT scan with clinical significance is not caused by COPD.
- •6. Syndrome differentiation of traditional Chinese medicine is phlegm heat obstructing lung, excessive lung heat, yin deficiency and lung heat.
- •7. Patients with angle closure glaucoma and third degree prostatic hypertrophy.
- •8. Patients with elevated AST and / or ALT = 2 times the upper limit of normal reference value, or SCR > the upper limit of normal reference value.
- •9. Patients with uncontrolled cardiovascular and cerebrovascular diseases, diabetes or other serious diseases such as hematopoietic system.
- •10. Patients with severe cognitive impairment or mental disorder, unable to complete the test, informed, unable to cooperate with clinical treatment and evaluation.
- •11. Pregnant or lactating women, or patients who wish to have children during the trial.
- •12. Participants in other clinical studies within 30 days before screening.
- •13. Allergic to the components of the study drug.
- •14. Association with the research center: the researcher, secondary researcher, research coordinator or employee of the researcher who is participating in the study or the immediate family members of the above-mentioned personnel are not allowed to participate in the study.
- •15. Patients who are not suitable for inclusion or for other reasons determined by researchers.
研究者
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