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

Phase 2

Completed

• Conditions: Bronchial Asthma
• Interventions: Other: warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum; Other: clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum; Other: securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum; Drug: Theophylline Sustained-release Tablets and budesonide suspension

• Registration Number: NCT01293734
• Lead Sponsor: Liaoning University of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Last Update Submitted: 2011-02-10
• Study First Posted: 2011-02-11
• Last Update Posted: 2011-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cold type	warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum	To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in cold type
heat type	clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum	To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in heat type.
Asthenia type	securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum	To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in Asthenia type.
Western medicine control group	Theophylline Sustained-release Tablets and budesonide suspension	-

Primary Outcome Measures

Name	Time	Method
primary Symptom	30 days	Symptom: wheezing, cough, choking
physical sign	30 days	physical sign: wheezing sound
assistant examination	30 days	Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC

Secondary Outcome Measures

Name	Time	Method
Secondary Symptom	30 days	Symptom: expectoration, fever, Aversion to wind and cold
physical sign	30 days	physical sign: tongue appearance and Pulse condition