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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014