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

Bronchial Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293734
• Other study ID #: sygzwu
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2011
• Last updated: February 10, 2011
• Start date: December 2008
• Est. completion date: February 2011

Study information

• Verified date: January 2011
• Source: Liaoning University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

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
• 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
• 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

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Liaoning University of Traditional Chinese Medicine	Benxi City hospital of Chinese medicine, Changda hospital in Anshan city, Shenyang Huanggu District Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary Symptom	Symptom: wheezing, cough, choking	30 days	No
Primary	physical sign	physical sign: wheezing sound	30 days	No
Primary	assistant examination	Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC	30 days	No
Secondary	Secondary Symptom	Symptom: expectoration, fever, Aversion to wind and cold	30 days	No
Secondary	physical sign	physical sign: tongue appearance and Pulse condition	30 days	No