Clinical Study on Treatment of Chronic Persistent Bronchial Asthma

Bronchial Asthma Clinical Trial

Official title:

Clinical Study on Treatment of Chronic Persistent Bronchial Asthma With Integrated Traditional Chinese and Western Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03228134
• Other study ID #: 2017LCSY347
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2018
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Zifeng Ma, Doctor
• Phone: +8621-64385700
• Email: mzf05[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• Ke Chuan Liu Wei Granule
Traditional Chinese Medicine
• Yang He Ping Chuan Granule
Traditional Chinese Medicine

Other:
• Ke Chuan Liu Wei Granule placebo
Placebo
• Yang He Ping Chuan Granule placebo
Placebo

Locations

Country	Name	City	State
China	Fenglin Street Community Health Service Center	Shanghai	Shanghai
China	Fengxian District Hospital of TCM	Shanghai	Shanghai
China	Kangjian Street Community Health Service Center	Shanghai	Shanghai
China	Longhua Hospital Affiliated Shanghai University of TCM	Shanghai	Shanghai
China	Tianping Street Community Health Service Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Longhua Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control rate change	Measured the change from Baseline of asthma control rate	up to 4 weeks
Secondary	Lung function(FEV1, PEF)	Measured routine pulmonary ventilation function test	Up to 4 weeks
Secondary	FeNO	The fractional concentration of exhaled nitric oxide	Up to 4 weeks
Secondary	Blood routine examination	Hematological routine examination	Up to 4 weeks
Secondary	Liver function test	Simple liver function test	Up to 4 weeks
Secondary	Cytokine levels of induced sputum	Measured cytokine levels of induced sputum supernatant	Up to 4 weeks
Secondary	Kidney function test	Simple kidney function test	Up to 4 weeks