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UNKNOWNPHASE4

Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)

Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis

NCT04834531•Zhong Wang

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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. -

Locations (4)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Sichuan Provincial Hospital of Traditional Chinese Medicine

Chengdu, Sichuan, China

Zhejiang Provincial Hospital of Chinese Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

July 1, 2021

Primary Completion Date

October 1, 2023

Completion Date

October 1, 2023

Last Updated

June 15, 2021

Enrollment

324

ESTIMATED participants

Conditions

Chronic Obstructive Pulmonary DiseaseChronic Bronchitis

Interventions

Zhuli capsule

DRUG

Placebo

DRUG

Standard medical treatment

OTHER

Contacts

Zhong Wang, M.D.

CONTACT

86-10-64093207 zhonw@vip.sina.com

Jun Liu, Ph.D.

CONTACT

86-10-64093207 franlj1104@aliyun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)

Inclusion Criteria

Exclusion Criteria

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