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Completed

NCT Number: NCT01293734

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.

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Key information

Conditions

Bronchial Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum

Other

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

Other

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

Other

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

Theophylline Sustained-release Tablets and budesonide suspension

Drug

Theophylline Sustained-release Tablets 0.2g a time, twice a day. budesonide suspension for inhalation 100ug, twice a day

Primary outcomes

  1. primary Symptom

    Time frame: 30 days

    Symptom: wheezing, cough, choking

  2. physical sign

    Time frame: 30 days

    physical sign: wheezing sound

  3. assistant examination

    Time frame: 30 days

    Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC

Secondary outcomes

  1. Secondary Symptom

    Time frame: 30 days

    Symptom: expectoration, fever, Aversion to wind and cold

  2. physical sign

    Time frame: 30 days

    physical sign: tongue appearance and Pulse condition

Sponsors and collaborators

Lead sponsor

Liaoning University of Traditional Chinese Medicine

Other

Collaborators

  • Anshan Central Hospital
  • Benxi City hospital of Chinese medicine
  • Shenyang Huanggu District Central Hospital

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 11, 2011
Registry last updated
Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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