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

Zhong Wang

Status and phase: Unknown; Phase 4

Conditions: Chronic Bronchitis; Chronic Obstructive Pulmonary Disease

Treatments: Other: Standard medical treatment; Drug: Placebo; Drug: Zhuli capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04834531

ZLJN-V2.0

Details and patient eligibility

About

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.

Enrollment: 324 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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324 participants in 2 patient groups, including a placebo group

Zhuli capsule

Experimental group

Description:

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.

Treatment:

Other: Standard medical treatment

Drug: Zhuli capsule

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Other: Standard medical treatment