Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.

Liaoning University of Traditional Chinese Medicine

Status and phase: Completed; Phase 2

Conditions: Bronchial Asthma

Treatments: Drug: Theophylline Sustained-release Tablets and budesonide suspension; Other: clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum; Other: warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum; Other: securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum

Study type: Interventional

Funder types: Other

Identifiers

NCT01293734

sygzwu

Details and patient eligibility

About

Bronchial asthma is a common disease and frequently encountered disease of respiratory apparatus. It has very complex mechanism and multiple inducing factors. This study will focus on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice. The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial asthma, and provide an effective therapy for this disease.

Enrollment: 360 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 to 65 years old;
• Patients with mild-to-moderate bronchial asthma on attacking stage;
• Without cardiopulmonary or other complications;
• To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome differentiation;
• Informed consent form is required to be signed.

Exclusion criteria

• Older than 65 years or younger than 18 years old;
• Pregnant woman or suckling period woman;
• Patients combine serious primary disease in liver, renal, cardiovascular and cerebrovascular, hemopoietic system diseases,or psychosis.
• Severe levels of disease is between severe and critical extent. Combine Pulmonary Heart Disease or respiratory failure;
• Irritable the physique, or allergic to the given composition of drugs in this research;
• Patients who are in the process of other clinical research.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 4 patient groups

cold type

Experimental group

Description:

To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in cold type

Treatment:

Other: warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum

heat type

Experimental group

Description:

To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in heat type.

Treatment:

Other: clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum

Asthenia type

Experimental group

Description:

To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in Asthenia type.

Treatment:

Other: securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum

Western medicine control group

Active Comparator group

Treatment:

Drug: Theophylline Sustained-release Tablets and budesonide suspension