Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 324
- 试验地点
- 4
- 主要终点
- The clinical control rate of sputum
研究概览
简要总结
This trial aims to evaluate the clinical control rate of sputum by Zhuli Capsule in the treatment of the Phlegm-heat Syndrome （Tan-re Zheng）in the patients with acute exacerbation of chronic obstructive pulmonary disease or chronic bronchitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of acute exacerbation in chronic obstructive pulmonary disease or chronic bronchitis;
- •Meet the diagnostic criteria of Phlegm-heat Syndrome (Tan-re Zheng) in TCM
- •Age from 18 to 75 years old, regardless of gender;
- •The score of each dimension of the sputum assement scale is ≥1;
- •Those who have not participated in other drug clinical research in the past one month;
- •Sign the informed consent letter.
排除标准
- •Patients with pulmonary tuberculosis, bronchial cancer or other lung diseases.
- •Loose stools due to Spleen deficiency and stomachache caused by cold.
- •Diabetes or severe cardiovascular, liver (ALT>1.5×ULN), kidney (Cr>1.5×ULN) and other primary diseases.
- •Pregnant and lactating women.
- •Patients with acute and chronic respiratory failure.
- •Those who cannot give full informed consent due to mental disorders.
- •People with disabilities recognized by law.
- •People with allergies, or allergic to the ingredients of the drug used in this test.
- •Those who have used drugs with expectorant effects within the day.
- •Patients who are participating in clinical trials of other drugs. -
研究组 & 干预措施
Placebo
Base on the standard medical treatment, the patients in this group will be used placebo capsule, 2 capsules (1.2 g) once, three time a day for 7 days.
干预措施: Placebo (Drug)
Placebo
Base on the standard medical treatment, the patients in this group will be used placebo capsule, 2 capsules (1.2 g) once, three time a day for 7 days.
干预措施: Standard medical treatment (Other)
Zhuli capsule
Base on the standard medical treatment, the patients in this group will be used Zhuli capsule, 2 capsules (1.2 g) once, three time a day for 7 days.
干预措施: Zhuli capsule (Drug)
Zhuli capsule
Base on the standard medical treatment, the patients in this group will be used Zhuli capsule, 2 capsules (1.2 g) once, three time a day for 7 days.
干预措施: Standard medical treatment (Other)
结局指标
主要结局
The clinical control rate of sputum
时间窗: Day 7
Defined as the proportion of patients with the expectoration rate ≥90%.
次要结局
- Time to sputum turn white(up to Day 7)
- Use of Antibiotic(0,Day 3, Day 7)
- The change value about the volume of sputum after treatment(0,Day 3, Day 7)
- Chronic obstructive pulmonary disease Assessment Test(0,Day 3, Day 7)
- Cough Symptom Score Scale(0,Day 3, Day 7)
- The Phlegm-heat Syndrome (Tan-re Zheng) scale(0,Day 3, Day 7)
研究者
Zhong Wang
Institute of Clinical Basic Medicine of Traditional Chinese Medicine
China Academy of Chinese Medical Sciences