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

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.

Study Overview

• Status: Completed
• Conditions: Bronchial Asthma
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cold type; To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in cold type	Other: warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum; warming lung and relieving asthmatic granule:once 1 bag, 3 times a day. Securing origin and warming lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day
Experimental: heat type; To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in heat type.	Other: clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum; clearing lung and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and clearing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day
Experimental: Asthenia type; To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in Asthenia type.	Other: securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum; securing origin and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and nourishing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day
Active Comparator: Western medicine control group	Drug: Theophylline Sustained-release Tablets and budesonide suspension; Theophylline Sustained-release Tablets 0.2g a time, twice a day. budesonide suspension for inhalation 100ug, twice a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Symptom	Symptom: expectoration, fever, Aversion to wind and cold	30 days
physical sign	physical sign: tongue appearance and Pulse condition	30 days

Collaborators and Investigators

• Sponsor: Liaoning University of Traditional Chinese Medicine
• Collaborators: Anshan Central Hospital; Shenyang Huanggu District Central Hospital; Benxi City hospital of Chinese medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Estimate): February 11, 2011
• Last Update Submitted That Met QC Criteria: February 10, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: symptoms; bronchial asthma; TCM syndrome; cold type; heat type; Asthenia type; physical signs
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Purinergic Antagonists; Purinergic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Budesonide; Theophylline
• Other Study ID Numbers: sygzwu