Back to resultsEffect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Zhuli capsule
Placebo
Standard medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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. -
Sites / Locations
- China-Japan Friendship Hospital
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sichuan Provincial Hospital of Traditional Chinese Medicine
- Zhejiang Provincial Hospital of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Zhuli capsule
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
The clinical control rate of sputum
Defined as the proportion of patients with the expectoration rate ≥90%.
Secondary Outcome Measures
Time to sputum turn white
Cough Symptom Score Scale
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.
Use of Antibiotic
Chronic obstructive pulmonary disease Assessment Test
The Phlegm-heat Syndrome (Tan-re Zheng) scale
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.
The change value about the volume of sputum after treatment
Monitor the sputum volume everyday and compare changes in sputum volume in the treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04834531
Brief Title
Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)
Official Title
Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng) in the Acute Exacerbations of Chronic Obstructive Pulmonary Disease or Chronic Bronchitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhong Wang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 obstructive pulmonary disease or chronic bronchitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
324 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zhuli capsule
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Zhuli capsule
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Other
Intervention Name(s)
Standard medical treatment
Intervention Description
Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include:
if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs;
if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks.
Primary Outcome Measure Information:
Title
The clinical control rate of sputum
Description
Defined as the proportion of patients with the expectoration rate ≥90%.
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Time to sputum turn white
Time Frame
up to Day 7
Title
Cough Symptom Score Scale
Description
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.
Time Frame
0,Day 3, Day 7
Title
Use of Antibiotic
Time Frame
0,Day 3, Day 7
Title
Chronic obstructive pulmonary disease Assessment Test
Time Frame
0,Day 3, Day 7
Title
The Phlegm-heat Syndrome (Tan-re Zheng) scale
Description
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.
Time Frame
0,Day 3, Day 7
Title
The change value about the volume of sputum after treatment
Description
Monitor the sputum volume everyday and compare changes in sputum volume in the treatment.
Time Frame
0,Day 3, Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong Wang, M.D.
Phone
86-10-64093207
Email
zhonw@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Liu, Ph.D.
Phone
86-10-64093207
Email
franlj1104@aliyun.com
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongchun Zhang, Prof.
Phone
86-10-84205298
Email
13701226664@139.com
Facility Name
Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Lin, Prof
Phone
86-20-81887233-34430
Email
drlinlin620@163.com
Facility Name
Sichuan Provincial Hospital of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing-Song Huang, Prof
Phone
86-28-87783481
Email
252465965@qq.com
Facility Name
Zhejiang Provincial Hospital of Chinese Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Wang, Prof.
Phone
86-571-86620303
Email
wangzhen610@sina.cn
12. IPD Sharing Statement
Learn more about this trial
Effect of Zhuli Capsule on Phlegm-heat Syndrome (Tan-re Zheng)
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