Clinical Study on Treatment of Chronic Persistent Bronchial Asthma

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03228134

Enrollment

320

Registered

2017-07-24

Start date

2018-02-01

Completion date

2024-09-30

Last updated

2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Keywords

treatment； bronchial asthma

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.

Interventions

DRUGKe Chuan Liu Wei Granule

Traditional Chinese Medicine

DRUGYang He Ping Chuan Granule

Traditional Chinese Medicine

OTHERKe Chuan Liu Wei Granule placebo

Placebo

OTHERYang He Ping Chuan Granule placebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Double-blind trial

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Asthma control rate change	up to 4 weeks	Measured the change from Baseline of asthma control rate

Secondary

Measure	Time frame	Description
FeNO	Up to 4 weeks	The fractional concentration of exhaled nitric oxide
Blood routine examination	Up to 4 weeks	Hematological routine examination
Lung function(FEV1, PEF)	Up to 4 weeks	Measured routine pulmonary ventilation function test
Cytokine levels of induced sputum	Up to 4 weeks	Measured cytokine levels of induced sputum supernatant
Kidney function test	Up to 4 weeks	Simple kidney function test
Liver function test	Up to 4 weeks	Simple liver function test

Countries

China

Contacts

Primary ContactZifeng Ma, Doctor

mzf05@126.com+8621-64385700

Backup ContactZhenghui Lu, PHD

tcmdoctorlu@163.com+8621-64385700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026