Back to resultsClinical Study on Treatment of Chronic Persistent Bronchial Asthma
Primary Purpose
Bronchial Asthma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ke Chuan Liu Wei Granule
Yang He Ping Chuan Granule
Ke Chuan Liu Wei Granule placebo
Yang He Ping Chuan Granule placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bronchial Asthma focused on measuring treatment； bronchial asthma
Eligibility Criteria
Inclusion Criteria:
- Patient diagnosed with chronic persistent asthma
- Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
- Conform to the predetermined 2 TCM Syndrome Types
- Patients who have given written informed consent
Exclusion Criteria:
- Smoking and continuous exposure to hazardous environment
- With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.
- Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
- Patients who are allergic to therapeutic medicine
Sites / Locations
- Fenglin Street Community Health Service CenterRecruiting
- Kangjian Street Community Health Service Center
- Tianping Street Community Health Service Center
- Longhua Hospital Affiliated Shanghai University of TCMRecruiting
- Fengxian District Hospital of TCMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Experimental
Sham Comparator
Arm Label
Hanxiao treatment group
Hanxiao control group
Xuxiao treatment group
Xuxiao control group
Arm Description
80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
Outcomes
Primary Outcome Measures
Asthma control rate change
Measured the change from Baseline of asthma control rate
Secondary Outcome Measures
Lung function(FEV1, PEF)
Measured routine pulmonary ventilation function test
FeNO
The fractional concentration of exhaled nitric oxide
Blood routine examination
Hematological routine examination
Liver function test
Simple liver function test
Cytokine levels of induced sputum
Measured cytokine levels of induced sputum supernatant
Kidney function test
Simple kidney function test
Full Information
NCT ID
NCT03228134
First Posted
July 17, 2017
Last Updated
May 24, 2023
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Longhua Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03228134
Brief Title
Clinical Study on Treatment of Chronic Persistent Bronchial Asthma
Official Title
Clinical Study on Treatment of Chronic Persistent Bronchial Asthma With Integrated Traditional Chinese and Western Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Longhua Hospital
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
Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.
Detailed Description
The incidence of asthma in China is high and the rate of control is low. Traditional Chinese medicine has a long history of treating asthma, and has a good clinical curative effect.The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.
In this study, investigators recruited chronic persistent asthma participants, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program for 28 days.Participants will undergo a physical examination, lung function, blood and sputum collection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
Keywords
treatment； bronchial asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
All treatment group received traditional chinese medicine plus a standard anti-asthma treatment on study entry, and the control group received placebo and standard anti-asthma treatment.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Double-blind trial
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hanxiao treatment group
Arm Type
Experimental
Arm Description
80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
Arm Title
Hanxiao control group
Arm Type
Sham Comparator
Arm Description
80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
Arm Title
Xuxiao treatment group
Arm Type
Experimental
Arm Description
80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
Arm Title
Xuxiao control group
Arm Type
Sham Comparator
Arm Description
80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
Intervention Type
Drug
Intervention Name(s)
Ke Chuan Liu Wei Granule
Other Intervention Name(s)
KCLW Granule
Intervention Description
Traditional Chinese Medicine
Intervention Type
Drug
Intervention Name(s)
Yang He Ping Chuan Granule
Other Intervention Name(s)
YHPC Granule
Intervention Description
Traditional Chinese Medicine
Intervention Type
Other
Intervention Name(s)
Ke Chuan Liu Wei Granule placebo
Other Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Other
Intervention Name(s)
Yang He Ping Chuan Granule placebo
Other Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Asthma control rate change
Description
Measured the change from Baseline of asthma control rate
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Lung function(FEV1, PEF)
Description
Measured routine pulmonary ventilation function test
Time Frame
Up to 4 weeks
Title
FeNO
Description
The fractional concentration of exhaled nitric oxide
Time Frame
Up to 4 weeks
Title
Blood routine examination
Description
Hematological routine examination
Time Frame
Up to 4 weeks
Title
Liver function test
Description
Simple liver function test
Time Frame
Up to 4 weeks
Title
Cytokine levels of induced sputum
Description
Measured cytokine levels of induced sputum supernatant
Time Frame
Up to 4 weeks
Title
Kidney function test
Description
Simple kidney function test
Time Frame
Up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient diagnosed with chronic persistent asthma
Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
Conform to the predetermined 2 TCM Syndrome Types
Patients who have given written informed consent
Exclusion Criteria:
Smoking and continuous exposure to hazardous environment
With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.
Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
Patients who are allergic to therapeutic medicine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zifeng Ma, Doctor
Phone
+8621-64385700
Ext
1307
Email
mzf05@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenghui Lu, PHD
Phone
+8621-64385700
Ext
1307
Email
tcmdoctorlu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huiyong Zhang, Director
Organizational Affiliation
tcmdoctorzhang@163.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fenglin Street Community Health Service Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuntao Yi, Master
Phone
+8618817338803
Email
yichuntao@126.com
Facility Name
Kangjian Street Community Health Service Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taiquan Huang, Master
Phone
+8613918375404
Email
tqh957@sina.com.cn
Facility Name
Tianping Street Community Health Service Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin He, Master
Phone
+8613501903509
Email
hexin2050@163.com
Facility Name
Longhua Hospital Affiliated Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zifeng Ma, Master
Phone
+8618817338863
Email
mzf05@126.com
Facility Name
Fengxian District Hospital of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201400
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Fang, Master
Phone
+8613816856217
Email
13816856217@139.com
12. IPD Sharing Statement
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Clinical Study on Treatment of Chronic Persistent Bronchial Asthma
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