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

Primary Purpose

Bronchial Asthma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum
clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum
securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum
Theophylline Sustained-release Tablets and budesonide suspension
Sponsored by
Liaoning University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchial Asthma focused on measuring bronchial asthma, cold type, heat type, Asthenia type, TCM syndrome, symptoms, physical signs

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    cold type

    heat type

    Asthenia type

    Western medicine control group

    Arm Description

    To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in cold type

    To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in heat type.

    To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in Asthenia type.

    Outcomes

    Primary Outcome Measures

    primary Symptom
    Symptom: wheezing, cough, choking
    physical sign
    physical sign: wheezing sound
    assistant examination
    Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC

    Secondary Outcome Measures

    Secondary Symptom
    Symptom: expectoration, fever, Aversion to wind and cold
    physical sign
    physical sign: tongue appearance and Pulse condition

    Full Information

    First Posted
    February 10, 2011
    Last Updated
    February 10, 2011
    Sponsor
    Liaoning University of Traditional Chinese Medicine
    Collaborators
    Shenyang Huanggu District Central Hospital, Benxi City hospital of Chinese medicine, Anshan Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01293734
    Brief Title
    Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Liaoning University of Traditional Chinese Medicine
    Collaborators
    Shenyang Huanggu District Central Hospital, Benxi City hospital of Chinese medicine, Anshan Central Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchial Asthma
    Keywords
    bronchial asthma, cold type, heat type, Asthenia type, TCM syndrome, symptoms, physical signs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    360 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    cold type
    Arm Type
    Experimental
    Arm Description
    To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in cold type
    Arm Title
    heat type
    Arm Type
    Experimental
    Arm Description
    To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in heat type.
    Arm Title
    Asthenia type
    Arm Type
    Experimental
    Arm Description
    To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in Asthenia type.
    Arm Title
    Western medicine control group
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Theophylline Sustained-release Tablets and budesonide suspension
    Intervention Description
    Theophylline Sustained-release Tablets 0.2g a time, twice a day. budesonide suspension for inhalation 100ug, twice a day
    Primary Outcome Measure Information:
    Title
    primary Symptom
    Description
    Symptom: wheezing, cough, choking
    Time Frame
    30 days
    Title
    physical sign
    Description
    physical sign: wheezing sound
    Time Frame
    30 days
    Title
    assistant examination
    Description
    Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Secondary Symptom
    Description
    Symptom: expectoration, fever, Aversion to wind and cold
    Time Frame
    30 days
    Title
    physical sign
    Description
    physical sign: tongue appearance and Pulse condition
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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