Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 324
- Locations
- 4
- Primary Endpoint
- The clinical control rate of sputum
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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. -
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Standard medical treatment (Other)
Outcomes
Primary Outcomes
The clinical control rate of sputum
Time Frame: Day 7
Defined as the proportion of patients with the expectoration rate ≥90%.
Secondary Outcomes
- 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)
Investigators
Zhong Wang
Institute of Clinical Basic Medicine of Traditional Chinese Medicine
China Academy of Chinese Medical Sciences