Clinical Study on Treatment of Chronic Persistent Bronchial Asthma

Shanghai University of Traditional Chinese Medicine

Status and phase: Enrolling; Phase 2

Conditions: Bronchial Asthma

Treatments: Other: Yang He Ping Chuan Granule placebo; Drug: Yang He Ping Chuan Granule; Drug: Ke Chuan Liu Wei Granule; Other: Ke Chuan Liu Wei Granule placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03228134

2017LCSY347

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 4 patient groups

Hanxiao treatment group

Experimental group

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.

Treatment:

Drug: Ke Chuan Liu Wei Granule

Hanxiao control group

Sham Comparator group

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.

Treatment:

Other: Ke Chuan Liu Wei Granule placebo

Xuxiao treatment group

Experimental group

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.

Treatment:

Drug: Yang He Ping Chuan Granule

Xuxiao control group

Sham Comparator group

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.

Treatment:

Other: Yang He Ping Chuan Granule placebo