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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Chronic Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Zhuli capsule

Intervention Type DRUG

This capsule is made from the exact of Phyllostachys glauca McClure or Phyllostachysnuda McClure, which has the expectorant effects. It is oral used,2 capsules for once, three times a day, for 7 days.

Standard medical treatment

Intervention Type OTHER

Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include:

1. if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs;
2. if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo capsule is filled with amylodextrin made with food colour and flavor，with the similar appearance, smell and flavor with Zhuli Capsule. It is oral used, 2 capsules for once, three times a day, for 7 days.

Standard medical treatment

Intervention Type OTHER

Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include:

1. if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs;
2. if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks.

Interventions

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Zhuli capsule

This capsule is made from the exact of Phyllostachys glauca McClure or Phyllostachysnuda McClure, which has the expectorant effects. It is oral used,2 capsules for once, three times a day, for 7 days.

Intervention Type DRUG

Placebo

The placebo capsule is filled with amylodextrin made with food colour and flavor，with the similar appearance, smell and flavor with Zhuli Capsule. It is oral used, 2 capsules for once, three times a day, for 7 days.

Intervention Type DRUG

Standard medical treatment

Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include:

1. if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs;
2. if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks.

Intervention Type OTHER

Eligibility Criteria

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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. -

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No