ITMCTR2200006022尚未招募4 期
Randomized, double-blind, positive drug parallel control, multi-center Chinese medicine variety protection clinical trial on the efficacy and safety of Baihe Gujin tablet in the treatment of chronic pharyngitis (lung-kidney yin deficiency syndrome)
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University0 个研究点开始时间: 待定最近更新:
适应症
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
- Observational study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(1) Meet the diagnostic criteria for chronic pharyngitis;
- •(2) Comply with the standard of TCM syndrome differentiation of lung and kidney yin deficiency;
- •(3) Age 18 to 65 years old (including 18 and 65 years old), gender is not limited;
- •(4) Subjects gave informed consent, voluntarily tested and signed the informed consent form.
排除标准
- •(1) Pharyngeal paraesthesia caused by chronic tonsillitis, styloid process syndrome, hyoid syndrome or other pharyngeal diseases, reflux esophagitis, bronchitis, early esophageal cancer, etc.;
- •(2) ALT and/or AST >1.5 upper limit of normal reference value; serum creatinine > upper limit of normal reference value; blood leukocyte <3.0×109/L or >10.0×109/L; and/or neutrophil (N) classification >80%; body temperature =37.3?;
- •(3) Patients who smoked or quit smoking for less than three months; or unavoidably exposed to dust or harmful gas for a long time;
- •(4) Those who have used drugs, non-drug treatments or health products that have a therapeutic effect on chronic pharyngitis within 1 week; or who have received pharyngeal surgery within 6 months;
- •(5) Combined with serious primary diseases of cardiovascular and cerebrovascular, liver, kidney, respiratory system, circulatory system, autoimmune system and hematopoietic system, or serious diseases that affect their survival, such as tumor or AIDS; of disabled patients;
- •(6) A history of alcohol and drug abuse or drug use in the past year;
- •(7) Pregnant or lactating women or those who are unwilling to take contraceptive measures during the test and within 1 month after the end of the test;
- •(8) Participated in another drug study within three months prior to enrollment;
- •(9) Those with allergic constitution or known ingredients of the drug;
- •(10)The investigators determined that there were other factors that were inappropriate for enrollment.
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