Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.
This study has been completed.
Sponsor:
Liaoning University of Traditional Chinese Medicine
Collaborators:
Shenyang Huanggu District Central Hospital
Benxi City hospital of Chinese medicine
Changda hospital in Anshan city
Information provided by:
Liaoning University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01293734
First received: February 10, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchial Asthma |
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 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Liaoning University of Traditional Chinese Medicine:
Primary Outcome Measures:
- primary Symptom [ Time Frame: 30 days ] [ Designated as safety issue: No ]Symptom: wheezing, cough, choking
- physical sign [ Time Frame: 30 days ] [ Designated as safety issue: No ]physical sign: wheezing sound
- assistant examination [ Time Frame: 30 days ] [ Designated as safety issue: No ]Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC
Secondary Outcome Measures:
- Secondary Symptom [ Time Frame: 30 days ] [ Designated as safety issue: No ]Symptom: expectoration, fever, Aversion to wind and cold
- physical sign [ Time Frame: 30 days ] [ Designated as safety issue: No ]physical sign: tongue appearance and Pulse condition
| Enrollment: | 360 |
| Study Start Date: | December 2008 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Zhenwu Guo, No.2 Affiliated Hospital of Liaoning University of Traditional Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT01293734 History of Changes |
| Other Study ID Numbers: | sygzwu |
| Study First Received: | February 10, 2011 |
| Last Updated: | February 10, 2011 |
| Health Authority: | China: State Administration of Traditional Chinese Medicine of the People's Republic of China |
Keywords provided by Liaoning University of Traditional Chinese Medicine:
|
bronchial asthma cold type heat type Asthenia type |
TCM syndrome symptoms physical signs |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Theophylline Budesonide Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors Vasodilator Agents Cardiovascular Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 16, 2013