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

June 13, 2021 updated by: Zhong Wang

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

324

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • China-Japan Friendship Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610075
        • Sichuan Provincial Hospital of Traditional Chinese Medicine
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Zhejiang Provincial Hospital of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: 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.
Other: 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.
PLACEBO_COMPARATOR: 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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The clinical control rate of sputum
Time Frame: Day 7
Defined as the proportion of patients with the expectoration rate ≥90%.
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to sputum turn white
Time Frame: up to Day 7
up to Day 7
Cough Symptom Score Scale
Time Frame: 0,Day 3, Day 7
Cough Symptom Score Scale include Day Cough Symptom Score and Night cough symptom score. In Day Cough Symptom Score, zero means no cough,one means occasionally short cough,two means frequent cough, slightly affecting daily activities,three means frequent coughing seriously affects daily activities;In Night cough symptom score,zero means no cough,one means short-term cough when falling asleep or occasional night cough,two means cough slightly affects night sleep,three means cough seriously affects night sleep.
0,Day 3, Day 7
Use of Antibiotic
Time Frame: 0,Day 3, Day 7
0,Day 3, Day 7
Chronic obstructive pulmonary disease Assessment Test
Time Frame: 0,Day 3, Day 7
0,Day 3, Day 7
The Phlegm-heat Syndrome (Tan-re Zheng) scale
Time Frame: 0,Day 3, Day 7
The Phlegm-heat Syndrome (Tan-re Zheng) scale include measures of the main symptoms and the secondary symptoms. The main symptom is about the color ，the characteristics and the amount of sputum.Each one includes four levels,0 represents normal，3 represents mild symptom,6 represents moderate symptom,9 represents Severe symptom.The secondary symptoms include Day cough，Night cough，Dry throat thirst，fever，blush，Dry stool，Yellow urine ，Red tongue and pulse.Each one includes different levels.The higher score represents the more meeting The Phlegm-heat Syndrome (Tan-re Zheng) ，the lower score means the opposite.
0,Day 3, Day 7
The change value about the volume of sputum after treatment
Time Frame: 0,Day 3, Day 7
Monitor the sputum volume everyday and compare changes in sputum volume in the treatment.
0,Day 3, Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhong Wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

April 5, 2021

First Posted (ACTUAL)

April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 13, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZLJN-V2.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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