Status:
UNKNOWN
Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)
Lead Sponsor:
Zhong Wang
Conditions:
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 obstructi...
Eligibility Criteria
Inclusion
- 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
- 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. -
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT04834531
Start Date
July 1 2021
End Date
October 1 2023
Last Update
June 15 2021
Active Locations (4)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
2
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510120
3
Sichuan Provincial Hospital of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610075
4
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, China, 310006