Clinical trial NCT04834531: Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)
Official title: Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria of acute exacerbation in chronic obstructive pulmonary disease or chronic bronchitis;
2. Meet the diagnostic criteria of Phlegm-heat Syndrome (Tan-re Zheng) in TCM
3. Age from 18 to 75 years old, regardless of gender;
4. The score of each dimension of the sputum assement scale is ≥1;
5. Those who have not participated in other drug clinical research in the past one month;
6. Sign the informed consent letter.

Exclusion Criteria:

1. Patients with pulmonary tuberculosis, bronchial cancer or other lung diseases.
2. Loose stools due to Spleen deficiency and stomachache caused by cold.
3. Diabetes or severe cardiovascular, liver (ALT\>1.5×ULN), kidney (Cr\>1.5×ULN) and other primary diseases.
4. Pregnant and lactating women.
5. Patients with acute and chronic respiratory failure.
6. Those who cannot give full informed consent due to mental disorders.
7. People with disabilities recognized by law.
8. People with allergies, or allergic to the ingredients of the drug used in this test.
9. Those who have used drugs with expectorant effects within the day.
10. Patients who are participating in clinical trials of other drugs. -

Primary outcomes:
measure: The clinical control rate of sputum
timeFrame: Day 7
Secondary outcomes:
measure: Time to sputum turn white
timeFrame: up to Day 7
measure: Cough Symptom Score Scale
timeFrame: 0,Day 3, Day 7
measure: Use of Antibiotic
timeFrame: 0,Day 3, Day 7
measure: Chronic obstructive pulmonary disease Assessment Test
timeFrame: 0,Day 3, Day 7
measure: The Phlegm-heat Syndrome (Tan-re Zheng) scale
timeFrame: 0,Day 3, Day 7
measure: The change value about the volume of sputum after treatment
timeFrame: 0,Day 3, Day 7
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Chengdu
country: China
facility: Sichuan Provincial Hospital of Traditional Chinese Medicine
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of Chinese Medicine
state: Zhejiang
Study officials:
References: